Topical fluoride for caries prevention - Geriatric Dentistry · of developing dental caries: 2.26% fluoride varnish or 1.23% fluoride (APF) gel, or a prescription-strength, home-use

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Topical fluoride for caries prevention

Full report of the updated clinical recommendations and supporting systematic review

A Report of the Council on Scientific Affairs November 2013

This report is intended to assist practitioners with decision-making about the use of topical-fluoride caries preventive agents to prevent caries. The recommendations in this document are not intended to define a standard of care and rather should be integrated with a practitioner’s professional judgment and a patient’s needs and preferences.

© 2103 ADA Center for Evidence-Based Dentistry. All rights reserved.

Background. A panel of experts convened by the American Dental Association (ADA) Council on Scientific Affairs presents evidence-based clinical recommendations on professionally-applied and prescription-strength, home-use topical fluoride agents for caries prevention. These recommendations are an update of the 2006 ADA recommendations regarding professionally applied topical fluoride, and were developed by using a new process that includes conducting the systematic review of primary studies.

Types of studies reviewed. The authors conducted a search of MEDLINE and the Cochrane Library for clinical trials of professionally-applied and prescription-strength topical fluoride agents – including mouthrinses, varnishes, gels, foams, and pastes – with caries increment outcomes published in English through October 2012.

Results. The panel included 71 trials in 82 articles in its review and assessed the efficacy of various topical fluoride caries-preventive agents. The panel makes recommendations for further research.

Clinical Implications. The panel recommends the following for people at risk of developing dental caries: 2.26% fluoride varnish or 1.23% fluoride (APF) gel, or a prescription-strength, home-use 0.5% fluoride gel or paste or 0.09% fluoride mouthrinse for 6 years or older. Only 2.26% fluoride varnish is recommended for children younger than 6 years. The strengths of the recommendations for the recommended products varied from “in favor” to “expert opinion for”. As part of the evidence-based approach to care, these clinical recommendations should be integrated with the practitioner’s professional judgment and the patient’s needs and preferences.

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Authors and acknowledgments

Authors

Robert J. Weyant, DMD, DrPH; Sharon L. Tracy, PhD; Theresa (Tracy) Anselmo, MPH, BSDH, RDH;

Eugenio D. Beltrán-Aguilar, DMD, MPH, MS, DrPH; Kevin J. Donly, DDS, MS; William A. Frese, MD;

Philippe P. Hujoel, MSD, PhD; Timothy J. Iafolla, DMD, MPH; William Kohn, DDS; Jayanth Kumar,

DDS, MDH; Steven M. Levy, DDS, MPH; Norman Tinanoff, DDS, MS; J. Timothy Wright, DDS, MS;

Domenick Zero DDS, MS; Krishna Aravamudhan, BDS, MS; Julie Frantsve-Hawley RDH, PhD; Daniel

M. Meyer, DDS; for the American Dental Association Council on Scientific Affairs Expert Panel on

topical fluoride caries preventive agents

Robert J. Weyant is Professor and Chair, Department of Dental Public Health, School of Dental Medicine,

University of Pittsburgh, Pittsburgh, PA. He was the chair of the panel.

Sharon L. Tracy is Assistant Director, Center for Evidence-Based Dentistry, Division of Science, American Dental

Association, Chicago. Address reprint requests to Dr. Tracy.

Theresa Anselmo is the Oral Health Program Manager, San Luis Obispo Health Agency, San Luis Obispo, CA.

She represented the American Dental Hygienists’ Association on the panel.

Eugenio D. Beltrán-Aguilar is Senior Epidemiologist and Advisor to the Director, Division of Oral Health, Centers

for Disease Control and Prevention, Atlanta, GA. He represented the Centers for Disease Control and Prevention

on the panel.

Kevin J. Donly is Professor and Chair, Pediatric Dentistry at the University of Texas Health Science Center San

Antonio, San Antonio, TX. He represented the American Academy of Pediatric Dentistry on the panel.

William A. Frese is Assistant Professor of Pediatrics at the University of Illinois at Chicago, Chicago, IL. He

represented the American Academy of Pediatrics on the panel.

Philippe P. Hujoel is Professor of Periodontics, Department of Dental Public Health Sciences, School of Dentistry,

University of Washington, Seattle, WA.

Timothy J. Iafolla is a Public Health Analyst, Office of Science Policy and Analysis, National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health, Bethesda, MD. He represented NIDCR on the panel.

William Kohn is vice president of dental science and policy, Delta Dental Plans Association, Oak Park, IL.

Jayanth Kumar is Director, Oral Health Surveillance and Research, Bureau of Dental Health, New York State Department of Health, Albany, NY and Associate Professor, School of Public Health, University at Albany.

Steven M. Levy is the Wright-Bush-Shreves Endowed Professor of Research, Department of Preventive and

Community Dentistry, College of Dentistry, and a professor, Department of Epidemiology, College of Public

Health, University of Iowa, Iowa City, IA.

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Norman Tinanoff is Professor and Division Chief, Pediatric Dentistry, School of Dentistry, University of Maryland,

Baltimore, MD.

J. Timothy Wright is Professor and Chair, Department of Pediatric Dentistry, School of Dentistry, University of

North Carolina, Chapel Hill, NC

Domenick Zero is Professor and Chair, Department of Preventive and Community Dentistry, Director, Oral Health

Research Institute, Associate Dean for Research, Indiana University, School of Dentistry, Indianapolis, IN.

Krishna Aravamudhan is Senior Manager, Office of Quality Assessment and Improvement, Division of Dental

Practice, American Dental Association, 211 E. Chicago Ave., Chicago, IL 60611, e-mail

[email protected].

Julie Frantsve-Hawley is Senior Director, Center for Evidence-based Dentistry, Division of Science, American

Dental Association, Chicago.

Daniel M. Meyer is Senior Vice President, Science/Professional Affairs, American Dental Association, Chicago.

Acknowledgments

The panel would like to acknowledge the efforts of the following individuals and their commitment in

helping complete this project.

Dr. Rocky Napier, ADA Council on Access, Prevention, and Interprofessional Relations (CAPIR)

Liaison; Ms. Jane McGinley, Manager, Fluoridation and Preventive Health Activities, ADA CAPIR Staff

Liaison; Dr. Douglas B. Torbush, ADA Council on Dental Practice (CDP) Liaison; Dr. C. Rieger Wood,

ADA Council on Dental Benefit Programs (CDBP) Liaison; Dr. William F. Robinson, ADA Council on

Dental Education and Licensure (CDEL) Liaison; Mr. Antanas Rasymas, ADA Library; Mr. Tom Wall,

ADA Health Policy Resources Center; Mr. Sam Cole, ADA Health Policy Resources Center.

The panel would like to thank the following individuals and organizations whose valuable input during

external peer review helped improve this report: Dr. Elliot Abt, Advocate Illinois Masonic Medical

Center; Dr. James Bader, University of North Carolina School of Dentistry; Dr. William H. Bowen,

University of Rochester School of Medicine and Dentistry; Dr. Albert Kingman, National Institute of

Dental and Craniofacial Research Center for Clinical Research; Dr. Stephen J. Moss, New York

University College of Dentistry; Dr. David G. Pendrys, University of Connecticut School of Dental

Medicine; Dr. Philip A. Swango, private dental consultant; Dr. Gary M. Whitford, Georgia Health

Sciences University School of Dentistry; Dr. Helen Worthington, Cochrane Oral Health Group,

University of Manchester School of Dentistry; the American Association for Dental Research (AADR);

the American Academy of Pediatric Dentistry (AAPD); the American Dental Hygienists’ Association

(ADHA); the National Institute of Dental and Craniofacial Research (NIDCR); the ADA Council on

Access, Prevention and Interprofessional Relations; the ADA Council on Communications; the ADA

Council on Dental Practice.

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The panel would like to thank the following individuals whose valuable input helped improve Table 1

and the chairside guide: Dr. Paul Fischl, Dr. Bob Kaspers, Dr. Dave Lewis, Dr. Dave McWhinnie, Dr.

Peter Neuhaus, and Dr. Maria Simon.

CDC Disclaimer: The work of the American Dental Association Council on Scientific Affairs Expert

Panel on Topical Fluoride Agents was supported in part by the U. S. Centers for Disease Control and

Prevention, Atlanta, GA. The findings and conclusions in this report are those of the authors and do not

necessarily represent the official position of the Centers for Disease Control and Prevention.

Disclosures: Robert J. Weyant, DMD, DrPH did not report any conflicts; Theresa (Tracy) Anselmo, MPH, BSDH, RDH served on the

Council on Public Health for the American Dental Hygienists' Association ending in June 2012; Eugenio D. Beltrán-Aguilar, DMD, MPH, MS,

DrPH is the Director of the American Board of Dental Public Health; Kevin J. Donly, DDS, MS is a Pediatric Dentistry Commissioner to the

ADA Commission on Dental Accreditation; William A. Frese, MD is the American Academy of Pediatrics Section VII Oral Health liaison and

also an advocate of oral health for the Illinois Oral Health Chapter of the American Academy of Pediatrics; Philippe P. Hujoel, MSD, PhD is a

Consultant to Delta Dental; Timothy Iafolla, DMD, MPH did not report any disclosures; William Kohn, DDS holds material financial interest in

a business that furnishes or is seeking to furnish goods or services to the ADA and publically represents Delta Dental Plans Association at

various meetings and events; Jayanth Kumar, DDS, MDH is the ASTDD Perinatal Committee Chair (2010 to present); Steven M. Levy, DDS,

MPH was the President of the American Board of Dental Public Health during the development of this report; Norman Tinanoff, DDS, MS is

on the Board of Trustees of the Dentaquest Foundation, an organization with a mission to improve access to oral health care, and receives no

compensation and occasionally does advocacy work for the University of Maryland Dental Action Coalition regarding oral health issues; J.

Timothy Wright, DDS, MS serves as a consultant to Edimer, which is a company working on ectodermal dysplasia protein therapy;

Domenick Zero, DDS, MS serves on the Johnson & Johnson Oral Care Advisory Board, receives compensation from Unilever for moderating

a symposium at the 2011 IADR Annual Meeting and consults on an ad hoc basis for GSK, Colgate, and P&G; Krishna Aravamudhan, BDS,

MS; Sharon L. Tracy, PhD; Julie Frantsve-Hawley RDH, PhD; Daniel M. Meyer, DDS have no disclosures.

Dr. Rocky Napier, ADA Council on Access, Prevention, and Interprofessional Relations (CAPIR) Liaison is a private practice dentist in Aiken,

South Carolina. He is also a member of the ADA Dental Practice Council, a mentor/local facilitator for the SC AAPD/OHS Head Start Dental

Home Initiative, a member of the Executive Board of the South Carolina Society of Pediatric Dentistry and a Liaison to the South Carolina

Dental Association. He is the Coordinator of the Aiken County Schools Dental Screening Program, and has been involved in several other

local dentistry-related organizations.

Dr. Douglas B. Torbush, ADA Council on Dental Practice Liaison is a Board Member of Fisher Foundation, which provides educational

loans/scholarships/grants to dental students and dental hygiene students in Georgia. He is also involved with Georgia Dental Associates

Legislative Awareness (LAW) Program, which lobbies Georgia Representatives on behalf of the patients of Georgia.

Dr. C. Rieger Wood, ADA Council on Dental Benefit Programs Liaison is the Dental Director of St. John Hospital Sapulpa and a part-time

Clinical Instructor at the University of Oklahoma College of Dentistry, Department of Operative Dentistry.

Dr. William F. Robinson, ADA Council on Dental Education and Licensure Liaison is a consultant for the Florida Board of Dentistry and the

Florida Department of Health.

Funding source: The ADA Council on Scientific Affairs commissioned this work and the Centers for

Disease Control and Prevention (CDC) partly funded this project.

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Introduction ...............................................................................................................................................................7

Clinical considerations and recommendations ....................................................................................................8

Balancing benefits with potential harms ...........................................................................................................9

Clinical Recommendations .............................................................................................................................. 10

Systematic review methods ................................................................................................................................ 12

Literature search ............................................................................................................................................... 12

Critical appraisal of included studies ............................................................................................................. 14

Data synthesis and meta-analysis ................................................................................................................. 15

Process for developing evidence statements ............................................................................................... 18

Deviations from the protocol ........................................................................................................................... 19

Methods for developing clinical recommendations .......................................................................................... 19

Results .................................................................................................................................................................... 22

Varnish: 2.26% and 0.1% fluoride .................................................................................................................. 23

Varnish (2.26% fluoride) .............................................................................................................................. 23

Evidence profiles: 2.26% fluoride varnish ................................................................................................. 26

Varnish (0.1% fluoride) ................................................................................................................................ 28

Evidence profiles: 0.1% fluoride varnish ................................................................................................... 30

APF gel (1.23% fluoride).................................................................................................................................. 31

General summary of results ........................................................................................................................ 31

Evidence statements .................................................................................................................................... 33

Evidence profiles: APF gel (1.23% fluoride) ............................................................................................. 34

APF foam (1.23% fluoride) .............................................................................................................................. 35



Evidence profiles: APF foam (1.23% fluoride) ......................................................................................... 35

Prophylaxis pastes containing fluoride .......................................................................................................... 37



Evidence profiles: prophylaxis pastes containing fluoride ...................................................................... 38

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Is prophylaxis prior to professional application of topical fluoride necessary? ........................................ 40



Evidence profiles: Prophylaxis prior to APF gel (1.23% fluoride) application ...................................... 41

Prescription-strength, home-use (0.5% fluoride) gel/paste agents ........................................................... 43



Evidence profiles: Prescription-strength, home-use (0.5% fluoride) gel/paste agents ...................... 45

Prescription-strength, home-use (0.09% fluoride) mouthrinse .................................................................. 47



Evidence profiles: Prescription-strength, home-use (0.09% fluoride) mouthrinse .............................. 50

Stannous fluoride .............................................................................................................................................. 51

Erupting teeth .................................................................................................................................................... 51

Systematic review conclusions ........................................................................................................................... 51

Limitations .............................................................................................................................................................. 52

Regarding the evidence ................................................................................................................................... 52

Regarding this systematic review ................................................................................................................... 53

Future research ..................................................................................................................................................... 53

References ............................................................................................................................................................. 55

Appendix 1 – Clinical Recommendations – detailed presentation ................................................................ 61

Appendix 2 – Literature searches ...................................................................................................................... 62

Appendix 3 – Excluded studies at full-text stage ............................................................................................. 64

Appendix 4 – Study characteristics, bias scores, and outcomes data tables .............................................. 81

Appendix 5 - Pragmatic calculations for interpreting summary estimates clinically ................................. 118

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Introduction In 2006, the Council on Scientific Affairs (CSA) of the American Dental Association (ADA) published

recommendations for the use of professionally-applied topical fluorides for caries prevention.1 Fluoride

is the primary agent available for caries prevention. The local availability of fluoride to the tooth surface

has been shown to prevent caries by primarily three mechanisms2, 3: 1) inhibiting demineralization of

tooth enamel; 2) enhancing remineralization of tooth enamel prior to lesion progression; and 3)

inhibiting the enzyme activity of cariogenic bacteria.

The objective of this report is to update the evidence at the 5-year interval according to ADA policy and

address additional questions related to the use of prescription-strength, home-use topical fluorides. In

this review the authors evaluated sodium, stannous, and acidulated phosphate fluoride for professional

and prescription home use, including varnishes, gels, foams, rinses and prophylaxis pastes. Not

included in this report are: over-the-counter products, slow release delivery devices, dental materials

that release fluorides and products based on sodium monofluorophosphate (MFP), silver diamine

fluoride, and titanium tetrafluoride. Sodium monofluorophosphate is primarily a non-prescription, daily

use fluoride product. Silver diamine fluoride and titanium tetrafluoride are not currently available in any

products in the U.S. For the remainder of this manuscript, the term “topical fluoride(s)” will be used to

include professionally-applied as well as prescription-strength, home-use products.

This report is intended to assist practitioners with decision-making about the use of topical fluoride

caries preventive agents. The panel notes that lack of clinical data, changes in formulations across

time, and a wide variety of products can hamper decision-making. The recommendations in this

document do not purport to define a standard of care, but rather should be integrated with each

practitioner’s professional judgment and each patient’s needs and preferences.

The authors addressed three clinical questions:

1. In primary and permanent teeth, does the use of a topical fluoride compared to no topical

fluoride reduce the incidence of new lesions, or arrestA or reverseA existing coronal and/or root

caries?

A Although the original clinical questions asked about arresting and reversing coronal and/or root caries,

insufficient data were found to answer the question; therefore, these outcomes are not addressed in these clinical recommendations.

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2. For primary and permanent teeth, is one topical fluoride agent more effective than another in

reducing the incidence of, or arrestingA or reversingA coronal and/or root caries?

3. Does the use of prophylaxis before application of topical fluoride reduce the incidence of caries

to a greater extent than topical fluoride application without prophylaxis?

Although improved clinical outcomes such as reduced need for treatment, enhanced quality of life,

increased function, decreased pain and tooth loss, and improved esthetics are the ultimate goal of

preventive interventions, outcomes such as reductions in incidence and progression (“arrests” or

“reversals”)A of caries are commonly reported outcomes for topical fluorides and thus are the a priori

outcomes measures chosen for these clinical recommendations.

The panel notes that clinical trials generally test the efficacy of an intervention, which results in the best

possible outcome for the intervention because of the controlled nature of the trial and strict

inclusion/exclusion criteria for participants. These results do not necessarily equate to effectiveness of

an intervention, i.e. how the intervention works in routine practice, which typically includes patients with

comorbidities who may be taking multiple medications. The efficacy is almost always higher than the

effectiveness because of the presence of idealized conditions. Several different topical fluoride

modalities, including those planned for home use, have been reviewed in this document. Practitioners

can expect different compliance with treatment plans incorporating home-use products compared to

products applied by the practitioner. Cost, efficacy, and/or effectiveness related to the intended usage

environment also may vary.

Clinical considerations and recommendations The grading system4 used in this report is adapted from the United States Preventive Service Task

Force (USPSTF) system5 and differs markedly from the system used originally in the 2006 Clinical

Recommendations.1 The difference is that current clinical recommendations are based on synthesis of

primary evidence collected via a de novo systematic review; whereas the previous clinical

recommendations were primarily based on published systematic reviews, with additional studies

included if published after the most recent systematic review. Another difference is that these

recommendations are based on the net benefit of the intervention, i.e. a balance of benefits to potential

harms, in conjunction with the level of certainty in the evidence, whereas the previous

recommendations were based solely on the design6 of studies on benefits. This has resulted in some

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modifications to the strength assigned to the individual recommendations for products reviewed in this

report compared to the 2006 Clinical Recommendations.

The current grading system includes the use of expert opinion as a means of making clinical

recommendations or not making clinical recommendations when evidence was lacking, contradictory,

or judged to be at high risk of bias, so that the panel could not reliably estimate the net benefit of the

intervention. Practitioners should note the strength of the recommendations and endeavor to

understand the level of certainty in the underlying evidence, as well as the balance of benefits to

potential harms. They should discuss uncertainties in evidence with their patients, providing awareness

that there is usually some level of uncertainty in the evidence used for clinical decision-making.

A practitioner should consider a patient’s risk of experiencing disease when developing an optimal

caries prevention plan. Part of a patient’s risk includes whether the patient lives in an optimally

fluoridated community and uses fluoridated toothpaste. Patients at low risk for caries may not need

additional fluoride interventions, whereas caries in very high risk individuals appears at times to be

largely refractory to additional intensive preventive interventions.7, 8

Professional judgment is required to interpret the clinical relevance of all effect measures to the

individual patient. The combination of the patient’s caries risk status, the practitioner’s professional

judgment, and a patient’s needs and preferences should guide decision-making. Patient education,

assessment of readiness for change, dietary advice, other preventive modalities, and periodic clinical

examinations should be considered as a part of the caries prevention plan. In public health settings,

additional considerations include the feasibility and cost of the proposed intervention. The panel did not

include these issues in providing its clinical recommendations.

Balancing benefits with potential harms

When considering any intervention, the practitioner and patient must balance the potential benefits with

the potential harms. The panel considered harms reported by included articles as well as known

potential harms of fluoride use. Potential harms of topical fluorides include, but may not be limited to,

the following:

1. Nausea and vomiting associated with the ingestion of topical fluorides.9

2. Dental fluorosis (an esthetic concern) while tooth enamel is developing until about age 6, due to

daily ingestion of topical fluoride, such as from toothpaste or from prescription home use gels.

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There is less of a concern with professionally-applied topical fluorides that have much longer

intervals between applications.10 Additionally, fluoride varnish has less potential for harms than

other forms of high concentration topical fluoride because the amount of fluoride that is placed in

the mouth with fluoride varnish is approximately one-tenth that of other professionally-applied

products.11

The panel judged that the benefits outweighed the potential for harms for all professionally-applied or

prescription-strength topical fluorides and age groups except for children under age 6, where the risk of

swallowing and associated events (particularly nausea and vomiting) outweighed the potential benefits

for all professionally-applied or prescription-strength topical fluorides except 2.26% fluoride varnish.

Clinical Recommendations

For individuals at elevated risk of developing dental caries, the panel made clinical recommendations

for the use of specific topical fluoride agents (as shown in Table 1); these recommendations are based

on the evidence statements and the balance of benefits with potential harm. The panel recommends

topical fluoride agents only for people at elevated risk for dental caries. Further details of the strength of

the clinical recommendations for each form of topical fluoride and age group are available in Appendix

1.

The panel recommends the following for people at risk of developing dental caries: 2.26% fluoride

varnish or 1.23% fluoride (APF) gel, or a prescription-strength, home-use 0.05% fluoride gel or paste or

0.09% fluoride mouthrinse for patients 6 years or older. Only 2.26% fluoride varnish is recommended

for children younger than 6 years. The strengths of the recommendations for the recommended

products varied from “in favor” to “expert opinion for”.

The panel judged that the benefits outweighed the potential for harm for all professionally applied and

prescription-strength, home-use topical fluoride agents and age groups except for children younger

than 6 years. In these children, the risk of experiencing adverse events (particularly nausea and

vomiting) associated with swallowing professionally applied topical fluoride agents outweighed the

potential benefits of using all of the topical fluoride agents except for 2.26 percent fluoride varnish.

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Table 1. Clinical recommendations for use of Professionally-applied or prescription-strength, home-use topical fluoride agents for caries

prevention in patients at elevated risk of developing caries

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Systematic review methods The authors represent a multidisciplinary panel of subject matter experts convened by the American Dental

Association (ADA) Council on Scientific Affairs (CSA). The panel conducted a comprehensive search of the

biomedical literature, screened the results of the search according to inclusion/exclusion criteria, critically

appraised the included studies, synthesized the data through meta-analyses where appropriate, evaluated the

level of certainty in the evidence regarding the magnitude of effect, and used a standardized process to

develop clinical recommendations. The supplemental materials (Appendices 2-4) contain further detailed

information for the interested reader as follows: Appendix 2 - search methods; Appendix 3 - detailed list of

excluded studies; and Appendix 4 - key information, risk of bias assessments, and extracted data from the

included studies.

Literature search

Two authors (KA and JF) used the strategy as presented in Appendix 2 to search MEDLINE through PubMed

and the Cochrane Library. In addition, two authors (KA and ST) hand-searched references of relevant recent

systematic reviews12-14 and other selected articles in order to include studies that might have been missed

through the electronic sources.

Figure 1 shows the process and results of the literature screening process. MEDLINE (through PubMed) was

searched from 1965 through March 4, 2011 resulting in 5,009 articles. An additional search of MEDLINE

(through PubMed) to identify articles on prescription-strength toothpaste was conducted on October 5, 2011 for

articles published since 1965 inclusive, which identified 23 articles. A second electronic database (The

Cochrane Library) was also searched from 1965 through March 4, 2011 resulting 1,281 articles. The electronic

database searches were all updated on August 30, 2012 resulting in 260 unique hits, for a total of 6,547

articles found. Through a hand-searching process, another 47 articles were identified for consideration.

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Two authors (KA and JF) independently screened the titles and abstracts using the inclusion and exclusion

criteria as shown in Table 2 and selected 402 articles for full-text review. One author (KA) reviewed the

manuscripts in full and identified articles for exclusion as reported in Appendix 3. Two members of the expert

panel (NT and TW) reviewed the reasons for exclusion and approved the final exclusion list. When a reviewer

was uncertain, she referred the papers to the expert panel members (NT and TW) for decision. Discrepancies

between reviewers were resolved by a third expert panel member and Chair of this workgroup (RW).

Figure 1: Flow diagram of the literature search and screening process

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Table 2. Inclusion/exclusion criteria

Inclusion criteria: Prospective human controlled clinical studies (randomized or non-randomized)

Fluoride agents requiring professional application or prescription

Studies that report caries incidence, arrest or reversal as outcomes

Exclusion criteria: Studies irrelevant to the topic

in vitro and animal studies

in situ studies using material surrogates (e.g., studies with removable appliances hosting enamel slabs)

Studies where the only reported outcome was increased salivary flow or reduction in Streptococcus mutans

Split-mouth designs

Cross-over design

Studies in which the experimental arm had other co-interventions (fluorides/OH instruction etc.) in which the control arm did not. (e.g., Exp: CHX + F; Control: F)

Studies that have sealants or toothpaste as the control group, except for studies that evaluated home use products

Studies reporting on fluoride-releasing dental materials

Studies reporting on slow release devices

Baseline caries data not reported

Abstracts only

Non English

Post-treatment results and effect of cessation of intervention

Products that are commercially available as OTC

APF Varnish

Studies that do not report the concentration of fluoride

Short-term (less than 1 year) studies unless the study reported frank cavitation in less than a year

Studies on products that are not commercially available in the U.S.

Critical appraisal of included studies: The grading system4 used in this report was adapted from the

United States Preventive Service Task Force (USPSTF) system5. The panel assessed the following four key

elements in their critical appraisal process: Randomization, allocation concealment, blinding and losses to

follow-up. All panel members participated in an orientation through a conference call to standardize the

application of the critical appraisal criteria. Each panel member received five to seven studies to review, along

with a standardized data abstraction form. Independent from the panel members, one of three authors (KA, JF,

or ST) duplicated the review and critical appraisal of all included studies independently and blinded to the

panel’s review. This ensured appraisal by two independent and blinded reviewers and standardized application

of the criteria by all reviewers. During a three-day face-to-face panel meeting, all panel members reviewed and

extensively discussed results from each study.

Each included trial was critically appraised according to the criteria displayed in Table 3, which are formatted

such that a “yes” response indicates low risk of bias. The number of “yes” answers was counted to provide a

risk of bias score. The numerical values of the risk of bias score generally can be interpreted as: 9-11 = low

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risk of bias; 7-8 = moderate risk of bias; and 0-6 = high risk of bias. Note that studies were assessed based on

the methods they reported, sometimes without certain knowledge of the methods actually used.

Table 3. Criteria for assessment of individual study risk of bias

Data synthesis and meta-analysis

Choice of outcome measures. Caries increment was the primary outcome measure, which is the number of

newly decayed, missing and/or filled surfaces or teeth experienced by each participant per year compared to

baseline. Caries increment is derived from longitudinal and not cross-sectional studies. The panel adapted a

set of rules published in a Cochrane review of caries trials15 to select outcome data from each study for

subsequent analysis. Specifically, the panel chose data for "all surface types combined" over data for “specific

types (surfaces)" only; data for "all erupted and erupting teeth combined" over data for "erupted" only, and this

over data for "erupting only"; data from "clinical and radiological examinations combined" over data from

"clinical" only, and this over "radiological" only; DMFS (dmfs) scores over DFS (dfs) or DS (ds); netB caries

B Net caries increment is obtained by subtracting the number of reversals (negative increments) from the number of

positive caries increments (Broadbent and Thomson 2005). 16. Broadbent J. M., Thomson WM. For debate: problems with the DMF index pertinent to dental caries data analysis. Community Dent Oral Epidemiol 2005;33(6):400-9.

Were patients in both study arms recruited from the same

population at the same time?

Randomization reported (random sequence generation)?

Randomization procedure described?

Allocation concealment claimed?

Blinding (examiner, patient and statistician)?

Rate of losses to follow-up similar between treatment

groups?

Baseline caries status of those lost to follow-up similar to

those remaining?

Baseline caries status similar between treatment groups at

end of study or adjustment for confounding?

Sample size estimated a priori (to ensure sufficient power)?

Intention to treat* used?

Conflict of interest absent?

*As defined by study author(s)

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increment data over crudeC (observed) increment data; and follow-up nearest to three years (often the one at

the end of the treatment period) over all other lengths of follow-up.

When data on both the tooth surface-level and tooth-level were available, the panel extracted data for both.

Similarly, the panel extracted data for “dentinal/cavitated” caries lesions, as well as for "all stages" (these data

are presented in Appendix 3). The panel also extracted data for primary and permanent teeth separately.

Imputing variances. When needed and possible, the panel imputed non-reported standard deviations using a

linear regression equation. 15

Adjusting for cluster-randomization. Some studies used group randomization (groups such as schools or

classes as opposed to individuals receiving the same intervention). In some of these studies, the results were

not adequately adjusted for the unit of analysis being the cluster rather than the individual. Standard statistical

procedures for adjustment for clustering depend on the number of clusters and the intracluster correlation

coefficient (ICC).17 The ICC ranges from 0 to 1, with the smaller number indicating the smaller cluster effect

and vice versa; however, it is often not reported, thus requiring estimation. 17,18 The standardized mean

differenceD (SMD) for three ICC values (0, 0.1, and 0.2) were calculated, and the resulting effects on the SMD

are presented, when applicable.

Effect estimates. Individual study results were combined by meta-analysis when multiple papers using

comparable methods were included for the same fluoride agent, with the objective of obtaining a more powerful

estimate of the true effect size. The SMD between the treatment and control arms was used as the effect

estimate, since it indicates whether the intervention is effective (i.e., works or does not work) and allows

measures on a variety of scales to be combined.

Data on cavitated surfaces were used in the meta-analysis calculations when both surface- and tooth-level

cavitated data were extracted. When only all stages data were reported, those data were also included in the

C Crude caries increment is obtained by comparing the baseline and follow-up status of each surface (on a surface-by-

surface basis). It does not allow for reversals. (Broadbent and Thomson 2005).16. Ibid.

D Standardized mean difference is the difference in means divided by a standard deviation. The standard deviation is the

pooled standard deviation of outcomes. The SMD value does not depend on the measurement scale, so it is a useful metric when outcomes are measured on different scales. What it actually measures is the number of standard deviations between the means. [Cochrane Handbook, Meta-analysis of continuous data, http://www.cochrane-net.org/openlearning/html/modA1-4.htm.]

http://www.cochrane-net.org/openlearning/html/modA1-4.htm

http://www.cochrane-net.org/openlearning/html/modA1-4.htm

17

meta-analysis with cavitated data. When only tooth-level cavitated data were reported, the data were

summarized separately.

For individual studies judged to be too clinically heterogeneousE to combine into a meta-analysis, SMD

between the treatment and control arms in each study was used as the summary estimate. Individual study

results (as SMD), if present, are shown in a table along with the meta-analysis results, and not presented

graphically in a forest plot. All analyses were designed to assess superiority, not equivalence.

Clinical interpretation issues. Other systematic reviews on topical fluorides12-14 presented prevented fraction

(PF), number needed to treat (NNT), and SMD as their effect estimates. The panel chose a pragmatic

approach to summarize and interpret the data, which was to summarize one effect estimate (SMD), and then

provide conversions of that estimate into both PF and NNT for those more familiar with these effect estimates.

The methods are described in Appendix 5, and the results are presented in each topical fluoride section. The

methods originate from the observation14 that the character of DMFS data (that mean caries increments are

similar to their standard deviations) implies that meta-analysis of SMD (the difference between two means

divided by an estimate of the within-group standard deviation) is similar in magnitude to PF (the difference in

mean caries increments between the treatment and control groups divided by the mean increment of the

control group). The panel notes that the regression equation used to convert SMD to PF in Appendix 5 was

derived from studies on topical fluorides reviewed in this report and is not generalizable beyond this report. In

addition, the NNT in this report was based on an annual caries increment of 1 DMFS in the control group.

Generating forest plots. Random-effects meta-analyses were conducted throughout to generate forest plots

using Review Manager (RevMan) 5.1 software19 when there were two or more combinable trials. The random

effects method (rather than the fixed effect method) is recommended when trial data are taken from the

literature and likely do not represent the same population.20 The random effects model is more conservative in

that the variance is composed of both the within-study and between-studies sampling errors. Individual study

and summary effect estimates were weighted by the inverse of the variance according to standard methods.21

Statistical heterogeneity. Heterogeneity in study results typically arises from differences in study methodology

and/or differences in the clinical aspects of the trial, such as populations, time period of the study, and/or

E Clinical heterogeneity arises from variability in participants, interventions, and outcomes studied. [Cochrane Handbook

for Systematic Reviews of Interventions, Version 5.1.0 (updated March 2011), Editors: Julian PT Higgins and Sally Green.]

18

topical fluoride dose.22 The panel assessed heterogeneity from the forest plots based on the I2 statistic

generated by Review Manager19 software. The statistical heterogeneity was interpreted as23: I2<50% is low;

50<I2<75% is moderate; and I2>75% is high.

Process for developing evidence statements

The first step in this process was to systematically compare the 95% confidence interval of the summary effect

estimate to the null for each intervention. If the 95% confidence interval of the summary effect estimate

included the line of no effect (zero for difference measures such as SMD), the topical fluoride was judged not

to have an effect. If the 95% confidence interval of the summary effect estimate did not include the line of no

effect, the topical fluoride was judged to have a statistically significant effect.

The next step in the development of evidence statements was to classify the level of certainty in the summary

effect estimate as high, moderate, or low, according to a standardized grading system (Table 4). The level of

certainty refers to the probability that the panel’s assessment of the effect of an intervention is correct.4 The

criteria for assessment include the risk of bias of the included studies, number of studies, number of

participants, and statistical heterogeneity among the studies; the consistency in the magnitude and direction of

the effect; and the generalizability of the findings to the populations of interest. The possibility of publication

bias was not assessed, since there were not enough studies in any category to make a reliable judgment.

Table 4. Level of Certainty categories for summary effect estimates*

Level of Certainty in Effect Estimate

Description

High

The body of evidence usually includes consistent results from well-designed, well-conducted studies in representative populations. This conclusion is unlikely to be strongly affected by the results of future studies.

This statement is strongly established by the best available evidence.

Moderate

As more information becomes available, the magnitude or direction of the observed effect could change, and this change could be large enough to alter the conclusion.

This statement is based on preliminary determination from the current best available evidence, but confidence in the estimate is constrained by one or more factors, such as:

the number, size, or risk of bias of individual studies;

inconsistency** of findings across individual studies;

limited applicability due to the populations of interest; or

lack of coherence in the chain of evidence.

19

Low

More information could allow a reliable estimation of effects on health outcomes.

The available evidence is insufficient to support the statement or the statement is based on extrapolation from the best available evidence. Evidence is insufficient or the reliability of estimated effects is limited by factors such as:

the limited number or size of studies;

important flaws in study design or methods leading to high risk of bias;

inconsistency** of findings across individual studies;

gaps in the chain of evidence;

findings not applicable to the populations of interest; or

a lack of information on important health outcomes.

*Adapted from the United States Preventive Services Task Force system **Inconsistency of findings is a concept incorporating direction of effect, similarity of point estimates, overlapping of confidence intervals, and statistical heterogeneity. Statistical heterogeneity (I

2) is interpreted as

23: I

2<50% is low;

50<I2<75% is moderate; I

2>75% is high. Direction of effect and overlapping confidence intervals are also taken into

account.

Finally, the panel used a consensus method to generate statements that summarized the evidence, including

whether or not the intervention was shown to be beneficial, the level of certainty in the underlying evidence,

and other clinical information with respect to the population, dentition type, and frequency of application for

each topical fluoride agent that was reviewed. The evidence statements were approved by majority vote.

Deviations from the protocol

Although the panel was interested in the effect of topical fluoride agents on the arrest and reversal of caries

progression as stated in clinical question #1, insufficient evidence was found on these outcomes. Therefore,

the panel decided to focus the clinical recommendations only on the reduction of caries increment as a

measure of caries prevention.

Regarding clinical question #2, the panel was interested in the comparative effectiveness of different topical

fluoride agents. Because insufficient evidence was found on which to base clinical recommendations, the panel

was unable to address this question.

Methods for developing clinical recommendations The panel developed clinical recommendations and graded the strength of the recommendations according to

a standardized process. The expert panel ascertained the net benefit rating by judging the balance of benefits

to the potential for harms. For example, if a topical fluoride was found to be effective, and the benefits were

judged to outweigh the harms, the net benefit was “benefit outweighs harms.”

20

The panel used the criteria displayed in Table 5 to combine the Level of Certainty with the Net Benefit Rating

to arrive at the strength of the recommendation (Strong, In Favor, Weak, Expert Opinion For, Expert Opinion

Against, or Against). Table 6 shows the definitions of these strengths of recommendations.

Table 5. Balancing Level of Certainty and Net Benefit Rating to arrive at recommendation strength

Level of Certainty

Net Benefit Rating

Benefits outweigh

potential harms

Benefits balanced with

potential harms

No benefit or potential harms

outweigh benefits

High Strong In Favor Against

Moderate In favor Weak Against

Low Expert Opinion For¥ or Expert Opinion Against¥

¥The USPSTF system defines this category as insufficient evidence and makes I-Statements. They do not make recommendations when the level of certainty in the

evidence is low.

Table 6. Definitions for the strength of recommendation:*

Recommendation strength

Definition

Strong Evidence strongly supports providing this intervention

In Favor Evidence favors providing this intervention

Weak Evidence suggests implementing this intervention after alternatives have been considered.

Expert Opinion For¥ Evidence is lacking; the level of certainty is low. Expert Opinion guides this recommendation

Expert Opinion Against¥ Evidence is lacking; the level of certainty is low. Expert Opinion suggests not implementing this intervention

Against Evidence suggests not implementing this intervention or discontinuing ineffective procedures

*Adapted from the USPSTF system ¥The USPSTF system defines this category as insufficient evidence and makes I-Statements. They do not make recommendations when the level of

certainty in the evidence is low.

21

Note that as described in Table 4 for Low level of certainty (when evidence is insufficient or reliability of

estimated effects is limited) and Table 5, the expert panel can still make a recommendation based on their

collective judgment, based on the available evidence. Upon agreement that the level of certainty in the effect

was low, and when the panel decided to make a clinical recommendation, the language of that

recommendation was discussed and amended until a majority of the panel was satisfied, as assessed by vote.

A summary of the steps the panel took to translate the evidence into clinical recommendation strength levels is

presented at the end of each treatment section (subdivided by age/dentition) with the subheading “Evidence

Profiles”.24 The bulleted list includes: 1) the level of certainty in the effect estimate (column 1 in Table 5); 2) the

benefit of the treatment presented in three formats (standardized mean difference [SMD], prevented fraction

[PF], and number needed to treat [NNT]); 3) potential harms associated with the treatment; 4) the panel’s

judgment of the benefit-to-potential-harm balance (“net benefit rating”, columns 2 through 4 in Table 5); and 5)

the resulting strength of the recommendation from Table 5. By making the judgments explicit, the panel hopes

the reader can understand the reasoning behind the clinical judgments that were made to develop the clinical

recommendations. The panel’s judgments are based on the best available data. Some topical fluorides could

perform better than others in various situations. The panel notes that mean effects are just that, i.e., average

results; and some patients could experience a very large effect, while others experience little effect. Similarly,

small effects for an individual patient can have large public health effects if they apply to a large part of the

population.25

The panel approved clinical recommendations by a simple majority vote. The panel sought comments on this

report from other subject matter experts, methodologists, epidemiologists and end-users before finalizing the

recommendations. The ADA Council on Scientific Affairs approved the final report for publication.

22

Results The panel included 71 trials in 82 published papersF to assess the efficacy of various topical fluoride agents for

preventing caries. When possible, data from the studies were combined through a meta-analysis. Results of

the quality assessment and the data synthesis are presented below. Table 7 presents the fluoride

concentrations of each topical fluoride agent evaluated, both as concentration of fluoride ion and concentration

of sodium fluoride.

Table 7. Fluoride ion and sodium fluoride concentrations of topical fluoride agents

Topical Fluoride Agent % F- ion % NaF

Professionally-applied

2.26% fluoride varnish 2.26 5.0

0.1% fluoride varnish 0.1 N/A*

Acidulated phosphate fluoride (APF) gel (with 0.1 M phosphoric acid)

1.23 2.7

Acidulated phosphate fluoride (APF) foam (with 0.1 M phosphoric acid)

1.23** 2.7**

Prophylaxis paste containing fluoride (most as APF) 1.23 2.7

Prescription-strength, home-use

Prescription-strength gels/pastes with or without acidulation (0.1M phosphoric acid)

0.5 1.1

Prescription-strength mouthrinses 0.09 0.2

*0.09% difluorsilane **Concentration of fluoride before dispensed. When delivered as foam by combining gel with air, the total amount of fluoride in the foam product is reduced.

Some general considerations to take into account in reviewing the evidence include: First, some of the studies

were done before the 1970’s, when dental caries rates among children were higher,26 the percentage of the

population receiving fluoridated water was substantially lower,27 and the percentage of people using fluoridated

dentifrice was much lower28. Second, some studies were conducted in countries with different levels of

background fluoride exposure, other caries preventive efforts, and caries prevalence. Lastly, the study

populations often could not be categorized in terms of caries risk and the panel could not extrapolate to the risk

categories as defined today. Therefore, caution is advised when extrapolating the results to today’s high-risk

populations, such as children at high risk for early childhood caries.

F Note that there are several cases where one study was cited by several papers. All papers are cited for each study in

these cases.

23

Varnish: 2.26% and 0.1% fluoride

There are over 30 fluoride-containing varnish products on the market today, with varying compositions

(including resin, solvent, and presence of tricalcium phosphate [TCP]) and delivery systems. These

compositional differences lead to widely variable pharmacokinetics, the effects of which remain largely

untested clinically. Through its literature search process, the panel found clinical trials on four brand name

products and decided to summarize the results based on the percentage of fluoride, which was either 2.26% or

0.1%. Further research revealed that products identified with an identical brand name (Fluor Protector) had a

compositional change in 1987 from 0.7% fluoride to 0.1% fluoride29. Since the 0.7% fluoride product is no

longer available commercially, these trials30-34 were not eligible for inclusion in this review. Therefore, the data

are subdivided by 2.26% and 0.1% fluoride varnish.

Varnish (2.26% fluoride)

General summary of results

The panel identified 17 randomized and five non-randomized clinical trials that evaluated 2.26% fluoride

varnish. There were six randomized31-33, 35-39 and two non-randomized40, 41 clinical trials concerning the primary

dentition, 11 randomized31-33, 42-52 and two non-randomized53, 54 clinical trials concerning the permanent

dentition, and one controlled55 clinical trial that combined results for both dentitions. The control groups were

no treatment, oral health counseling, or placebo varnish. The studies were carried out in populations with

various levels of dental caries. The studies were conducted in many countries (Brazil, Canada, Hong Kong,

India, Kuwait, Netherlands, Poland, Spain, Sweden, U.K. and U.S.), with and without additional fluoride use or

other fluoride exposures (although most studies were in low fluoride areas), and with and without prior

prophylaxis. The ages of the children at baseline varied from 6 months to 8 years for studies of the primary

teeth; and 5 to 15 years for studies of the permanent teeth. The panel identified two studies50, 51 of root caries.

The age range in these two studies was 44 to 79 years. The varnish was professionally applied every 3 to 12

months, with the majority of studies applying varnish every 6 months.

The study characteristics, bias scores, and the extracted outcomes data are presented in Tables A through C

in Appendix 4. The bias scores ranged from 2 to 11 for the studies on primary and permanent teeth.

The panel combined the surface-level data for studies comparing varnish application to placebo or no

treatment into two meta-analyses, one each for the primary and permanent dentitions. These meta-analyses

are shown in Figures 2 and 3. Some studies were not included in the meta-analysis because the results for

primary and permanent teeth were combined55, only tooth-level data were reported53, and only data on the

occlusal surfaces of the first permanent molars were reported45.

24

The results of two root caries studies50, 51 were combined in a separate meta-analysis (Figure 4).

Table 8 summarizes the SMD from all the studies, separated into those results generated via meta-analysis

and those of individual studies (not included in the meta-analysis).

Figure 2. Standardized mean differences from meta-analysis of 2.26% fluoride varnish studies on

primary teeth [d(e/m)fs]

Notes: 1) Adjustment for cluster randomized trials (Grodzka) at ICC=0.1: -0.20 [-0.32, -0.08], I2=58%; at ICC=0.2: -0..20 [-0.32, -0.08], I

2=57%; 2) For

Clark, used Cochrane regression equation for imputing SD; 3) For Autio-Gold and Gugwad, calculated the change between baseline and final

measurements, assuming r=0.5 for SD calculation; 4) For Weintraub, ITT data used combining both treatment arms; 4) For Hardman, converted SE to

SD; 5) For Lawrence, used “adjusted means for aboriginal only” data, and converted SE (2.04) to SD using the adjusted difference according to SD =

SE/(sqrt(1/832+1/328)).


permanent teeth [DMFS]

Notes: 1) Koch-SE converted to SD using the adjusted difference according to SD = SE/(sqrt(1/60+1/61)); 2) Modéer-mean prevalence at 3 years adding

“Decayed 03” plus “Filled” data; and used Cochrane regression equation for imputing SD; 3) For Clark, used Cochrane regression equation for imputing

SD; 4) Tewari converted SE to SD using the same approach as for Koch SE; 5) Bravo added fissured and non-fissured means for total surface mean;

not cluster adjusted in this figure; used Cochrane regression equation for imputing SD; 6) Milsom used “Total DFS increment - Mean of cluster

summaries” data with the number of clusters used as the sample size.

Sensitivity analysis: Adjustment for cluster randomized trials (Bravo) at ICC=0.1: -0.37 [-0.52, -0.23], I2=65%; at ICC=0.2: -0.37 [-0.51, -0.22], I

2=64%

25


decayed root caries surfaces

Table 8. Summary of standardized mean differences from meta-analysis and individual studies for 2.26% fluoride varnish studies

Outcome Measures Number

and type* of studies

Number of participants**

Standardized Mean Difference [95% Confidence Interval]

(negative favors intervention, positive favors control)

Meta-analysis results: Primary teeth

d(e/m)fs, increment or incidence †

6 RCT31-33,

35-39 and 2 CCT40, 41

3,409** -0.19 [-0.31, -0.08]

Meta-analysis results: Permanent teeth

D(M)FS, increment or incidence†

8 RCT31-33,

42-44, 46-49, 52 and 1 CCT54

2,574 -0.38 [-0.53, -0.24]

Root caries, meta-analysis results

Root caries increment 2 RCT50, 51 132 -0.67 [-1.14, -0.20]

Individual study results

Combined dentition 1 CCT55 390 DMFS + dmfs: -1.47 [-1.70, -1.25] DMFT + dmft: -1.15 [-1.37, -0.94]

DMFT 1 CCT53 77 -0.13 [-0.58, 0.32]

DS occlusal surfaces 1 RCT45 79 -0.54 [-1.06, -0.03] Notes: * RCT = randomized controlled trial; CCT = controlled clinical trial (non-randomized); **Including all participants (not using cluster-adjusted number of participants or numbers of clusters);

†all stages used if cavitated data not available; parentheses indicate that component was included in

some of the combined results and not others

The results of the meta-analyses for primary teeth (Figure 2) indicate that the application of 2.26% fluoride

varnish has a statistically significant effect (SMD -0.19 [95% CI: -0.31, -0.08]) on caries prevention as

measured by increment or incidence using surface-level data.

The results of the meta-analyses for permanent teeth (Figure 3) indicate that 2.26% fluoride varnish has a

statistically significant effect (SMD= -0.38 [95% CI: -0.53, -0.24]) on caries prevention as measured by

increment or incidence using surface-level data. Several studies provided data that could not be included in the

meta-analysis, the results of which are summarized in Table 8.

26

In addition, two RCTs on root caries indicated a statistically significant improvement in root caries prevention

as shown in Figure 4.

Evidence statements

The panel concluded with moderate certainty that there is a benefit of 2.26% fluoride varnish application

at least twice per year for caries prevention in the primary teeth among children aged 6 months to 8

years. This statement is based on meta-analysis of seven studies that ranged from low to high risk of bias and

included over 3,000 participants; however, it is noted that there was moderate statistical heterogeneity

(I2=58%) and inconsistency among the results of the studies.

The panel concluded with moderate certainty that there is a benefit of 2.26% fluoride varnish application

at least twice per year for caries prevention in the permanent teeth among children aged 5 to 15 years.

This statement is based on meta-analysis of nine studies that ranged from low to high risk of bias and included

over 4,500 participants; however, it is noted that there was moderate statistical heterogeneity (I2=68%) and

some inconsistency among the results of the studies.

The panel concluded with low certainty that there is a benefit of 2.26% fluoride varnish application at

least twice per year for root caries prevention in adults with root caries. This statement is based on meta-

analysis of two studies with low to moderate risk of bias that included only 132 participants, but there was low

statistical heterogeneity (I2=28%), showing a consistent effect between the two studies.

The panel identified no studies of the effect on coronal caries of 2.26% fluoride varnish on the permanent teeth

of adults over the age of 18.

Evidence profiles: 2.26% fluoride varnish

Primary teeth (children under age 6):

Level of certainty: Moderate

Benefit: Yes (smaller caries increment or incidence with topical fluoride use). o SMD=-0.19 [-0.31, -0.08] o PF=0.22 o NNT for control rate of 1 dmfs per year = 4

Adverse events or harms: Little potential for harms if swallowed

Benefit-harm assessment (Net benefit rating): Benefits outweigh potential harms

Strength of clinical recommendation: In favor

Permanent teeth (children):


Benefit: Yes (smaller caries increment or incidence with topical fluoride use). o SMD=-0.38 [-0.53, -0.24] o PF=0.36

27

o NNT for control rate of 1 DMFS per year = 3

Adverse events or harms: None if used as manufacturers recommend


Strength of clinical recommendation: In favor Permanent teeth – coronal caries (adults):

Level of certainty: No certainty (no studies)

Benefit: Unknown, but extrapolated from permanent teeth of children data



Strength of clinical recommendation: Expert opinion for use Permanent teeth - root caries (adults):

Level of certainty: Low

Benefit: Yes (smaller caries increment or incidence with topical fluoride use). o SMD=-0.67 [-1.14, -0.20] o PF=0.58 o NNT for control rate of 1 DMFS per year = 2



Strength of clinical recommendation: Expert opinion for use

28

Varnish (0.1% fluoride)


The panel identified two non-randomized clinical trials56, 57 that evaluated 0.1% fluoride varnish on the

primary dentition and one randomized clinical trial58 on the permanent dentition. The control groups

received oral hygiene instruction or no treatment. The studies were carried out in Germany and Sweden

in populations with various baseline levels of dental caries. The ages of the children at baseline varied

from 4 to 5 years for primary dentition and 9 to 12 years for permanent dentition. The varnish was

professionally applied every 6 months for the primary dentition and every 4 months for the permanent

dentition. Additional fluoride use or other fluoride exposure was variable, and all studies included prior

prophylaxis.

The study characteristics, bias scores, and extracted outcomes data are presented in Tables D through

F in Appendix 4. The bias scores were 2 for the two clinical trials and 6 for the RCT.

The panel compared varnish application to no treatment in one meta-analysis for the primary dentition

as shown in Figure 5. Table 9 summarizes the meta-analysis results and also lists the single-study

results for the permanent dentition.

Figure 5. Standardized mean differences from meta-analysis of studies of 0.1% fluoride varnish

applied twice a year to primary teeth [d(e/m)fs]

Notes: Twetman and Petersson not cluster adjusted in figure.

Sensitivity analysis: Adjustment for cluster randomized trials (Twetman and Petersson) at ICC=0.1: -0.05 [-0.30, 0.20], I2=0%; at ICC=0.2: -0.05

[-0.40, 0.29], I2=0%

29

Table 9. Summary of standardized mean differences from meta-analysis and individual studies for 0.1% fluoride varnish

Outcome Measures

Number and type* of studies




Primary teeth, meta-analysis results

dfs increment or incidence

2 CCT56, 57 4,977 -0.11 [-0.27, 0.06]

Permanent teeth, individual study results

DMFS increment 1 RCT58 318 -0.15 [-0.37, 0.08] Notes: * RCT = randomized controlled trial; CCT = controlled clinical trial (non-randomized); **Including all participants (not using cluster-adjusted number of participants)

The estimate of effect of 0.1% fluoride varnish applied twice per year on the primary teeth shows no

statistically significant effect, as shown in Figure 5.

The estimate of effect of 0.1% fluoride varnish applied at least once per year on the permanent dentition

is not statistically significant, as shown in Table 9.

Evidence statement

The panel concluded with moderate certainty that there is no benefit of 0.1% fluoride varnish

application twice per year for caries prevention of primary teeth among children less than 6

years old. This statement is based on meta-analysis of two studies at high risk of bias with almost 5,000

participants; however, the results were inconsistent with high statistical heterogeneity (I2=79% without

cluster adjustment). Furthermore, when adjusted for clustering, the statistical heterogeneity was

eliminated (I2=0%).

The panel concluded with low certainty that there is no benefit of 0.1% fluoride varnish application

three times per year for caries prevention of permanent teeth among children aged 6-14 years

old. This statement is based on one study at high risk of bias with 318 participants.

The panel identified no studies on the effect of 0.1% fluoride varnish on coronal or root caries on the

permanent teeth of adults over the age of 18.

30

Evidence profiles: 0.1% fluoride varnish



Benefit: No

Adverse events or harms: Little potential for harms if swallowed

Benefit-harm assessment (Net benefit rating): No benefit

Strength of clinical recommendation: Against



Benefit: No



Strength of clinical recommendation: Expert opinion against use Permanent teeth – coronal caries (adults):





Strength of clinical recommendation: Expert opinion against use Permanent teeth – root caries (adults):


Benefit: Unknown


Benefit-harm assessment (Net benefit rating): Unknown

Strength of clinical recommendation: Panel unable to make a recommendation

31

APF gel (1.23% fluoride)


The panel identified 11 randomized59-70 and four non-randomized 55, 71-75 clinical trials that evaluated APF gel

(1.23% fluoride as Acidulated Phosphate Fluoride [APF], 0.1 M phosphoric acid) quarterly, semiannually,

annually or biennually (one application observed after 2 years). The comparison groups received no treatment,

placebo, prophylaxis, or non-fluoride placebo gel. All studies except one71 were on permanent teeth. All

studies applied fluoride gel for four minutes.

The study characteristics, bias scores, and the extracted outcomes data are presented in Tables G through I in

Appendix 4. All studies were conducted on school-aged children (between 3 and 16 years old) except for

one69. One study69 was conducted on non-institutionalized adults at least 60 years of age and reported on root

caries. Ten studies were conducted in the U.S. and five elsewhere (India55 70, U.K.66, China65 and Canada67).

The bias scores of eight55, 59-61, 64, 66, 69, 71, 75 of the studies ranged from 3 to 6, and seven55, 56, 58, 60, 61 70, 72-74, 76

were rated as 7. Although most studies used blinded assessment of outcomes, these bias scores were driven

primarily by lack of reporting of the randomization procedure, allocation concealment, and use of intention-to-

treat analysis.

The panel combined the results of 12 studies on permanent teeth through a meta-analysis that was grouped by

frequency of application. Three of the studies were excluded from the meta-analysis because of clinical

heterogeneity (the participants were older adults and the outcome was root caries increment)69 and because of

non-comparable outcomes measures (results combined for primary and permanent teeth55; and primary teeth

only71). Figure 6 presents the results of the meta-analysis.

32

Figure 6. Standardized mean differences from meta-analysis of studies of APF gel (1.23% fluoride)

applied on permanent teeth [DMFS] grouped by frequency of application

Notes: Jiang not cluster-adjusted in figure because ICC is not known, but adjustment at ICC=0.1: -0.25 [-0.34, -0.17], I2=42%; and at ICC=0.2: -0.26 [-

0.35, -0.17], I2=42%.

The meta-analysis (Figure 6) shows statistically significant reduction of dental caries in permanent teeth with

professionally-applied 1.23% APF gel at 3- to 24-month intervals compared to no treatment, placebo, or

prophylaxis. All application frequencies had statistically significant overall effects.

Table 10 summarizes the standardized mean differences from all the studies, separated into those generated

via meta-analysis and those of individual studies (not included in the meta-analysis).

33

Table 10. Summary of standardized mean differences from meta-analysis and individual studies for professionally-applied APF gel (1.23% fluoride)

Outcome Measures Number and

Type* of studies Number of

participants**



Meta-analysis results:

D(M)FS, increment or incidence†, all frequencies

10 RCT59-68, 70 / 2 CCT72-75

4,023 -0.25 [-0.33, -0.16]

Individual trial results:

dmfs increment 1 CCT71 255 -1.51 [-1.79, -1.23]

DMFS + dmfs increment, all stages

1 CCT55 390 -0.84 [-1.05, -0.63]

Root caries DMFS increment, adults older

than 60 1 RCT69 318 -0.22 [-0.44, -0.00]

Notes:* RCT = randomized controlled trial; CCT = controlled clinical trial; **Using non-cluster-adjusted participant numbers; †

All stages used if cavitated

data not available

Professionally-applied APF gel was shown to have a statistically significant effect on caries increment for the

mixed dentition55, as well as primary teeth71; however, the effect on root caries in adults older than 60 was

marginally statistically significant.69

Evidence statements

The panel concluded with low certainty that there is a benefit of APF gel (1.23% fluoride) application up

to every three months for 4G minutes for caries prevention in the primary dentition. This statement is

based on one study with a high bias score that included 255 participants.

The panel concluded with moderate certainty that there is a benefit of APF gel (1.23% fluoride)

application up to every three months for 4G minutes for caries prevention in the permanent teeth of 6-

14 year olds. This statement is based on meta-analysis of 12 studies with moderate to high bias scores and

including over 4,000 participants; although there was some inconsistency, there was low statistical

heterogeneity (I2=43) between the studies.

The panel concluded with low certainty that there is a benefit of APF gel (1.23% fluoride) application 2

times per year for 4G minutes to prevent root caries. This statement is based on one study with a high bias

score including 318 participants.

G No studies were found on professionally-applied fluoride APF gels with an application time of less than 3 minutes.

34

The panel identified no studies on the effect of 2% NaF gel meeting study criteria. In addition, the panel

identified no studies of APF gel (1.23% fluoride) on the coronal surfaces of permanent teeth of adults over the

age of 18.

Evidence profiles: APF gel (1.23% fluoride)



Benefit: Yes (smaller caries increment or incidence with topical fluoride use). o SMD=-1.51 [-1.79, -1.23]

Adverse events or harms: Potential harms if swallowed

Benefit-harm assessment (Net benefit rating): Potential harms could outweigh benefits

Strength of clinical recommendation: Expert opinion against use













Benefit: Yes (smaller caries increment or incidence with topical fluoride use) o SMD=-0.22 [-0.44, 0] o PF=0.24 o NNT for control rate of 1 DMFS per year = 4




35

APF foam (1.23% fluoride)


The panel identified two randomized clinical trials65, 77 that evaluated APF foam (1.23% fluoride) in children

aged 3-7 years at baseline, one in the primary and the other in the permanent dentition. The comparison group

received either no treatment or placebo. Both studies were done in China.

The panel judged the bias score of one77 of the studies to be 9, while the other65 was judged to be 7. The study

characteristics, bias scores, and the extracted outcomes data are presented in Tables J through L in Appendix

4. The results for each study are shown in Table 11.

Table 11. Summary of standardized mean differences from individual studies for APF foam (1.23% fluoride)

Outcome Measures





dmfs increment 1 RCT77 318 -1.26 [-1.50, -1.02] †

DMFS increment 1 RCT65 412 -0.14 [-0.34, 0.04]‡ Notes:* RCT = randomized controlled trial; CCT = controlled clinical trial (non-randomized); **Using non-cluster adjusted numbers of participants; † Adjustment for cluster randomized trials (Jiang and Tai) at ICC=0.1: -1.26 [-1.68, -0.84]; at ICC=0.2: -1.25 [-1.79, -0.71]

Adjustment for cluster randomized trials (Jiang and Bian) at ICC=0.1: -0.14 [-0.59, 0.31]; at ICC=0.2: -0.14 [-0.75, 0.48]

Evidence statements

The panel concluded with low certainty that there is a benefit of APF foam (1.23% fluoride) application 2

times per year for 4H minutes for caries prevention in the primary dentition. This statement is based on

one study with a low bias score including 318 participants.

The panel concluded with low certainty that there is no benefit of APF foam (1.23% fluoride) application 2

times per year for 4H minutes for caries prevention in the permanent dentition of children. This

statement is based on one study with a moderate bias score including 412 participants.

Evidence profiles: APF foam (1.23% fluoride)



Benefit: Yes (smaller caries increment or incidence with topical fluoride use). o SMD=-1.26 [-1.50, -1.02]

Adverse events or harms: Potential for harm if swallowed



H Both studies on professionally-applied fluoride APF foams used an application time of 4 minutes.

36



Benefit: No



Strength of clinical recommendation: Expert opinion against use Permanent teeth – coronal caries (adults):





Strength of clinical recommendation: Expert opinion against use Permanent teeth - root caries (adults):


Benefit: Unknown




37

Prophylaxis pastes containing fluoride


The panel identified three randomized78-80 and three non-randomized81-83 clinical trials that evaluated the

annual or semiannual application of prophylaxis pastes, most containing 1.23% fluoride as APF, for caries

prevention. These studies were all conducted in the 1960s-1970s. The comparison groups received pumice

prophylaxis or placebo paste. All studies except one83 (on children 3-5 years old at baseline) were on the

permanent teeth of children 8-16 years old at baseline.

The study characteristics, bias scores, and the extracted outcomes data are presented in Tables M through O

in Appendix 4. All of the studies were conducted in the U.S. The panel judged five of the studies to have bias

scores ranging from 3 to 5, and one with a bias score of 7.78 These judgments of quality were primarily driven

by lack of randomization; and if randomized, lack of reporting of the randomization procedure, allocation

concealment, and/or use of intention-to-treat analysis.

The panel combined the results of five of the studies through a meta-analysis. One of the studies83 was

excluded from the meta-analysis because of clinical heterogeneity (primary teeth). Two studies80, 81 reported

the results of two examiners separately; to be conservative, the data from the examiner with the largest

standard deviation were used. Standard deviations were imputed for two studies.82, 83 Figure 7 presents the

results of the meta-analysis on cavitated lesions of decayed surfaces. Table 12 summarizes the standardized

mean differences for both primary (one study) and permanent (5 studies) teeth.

Figure 7. Summary of standardized mean differences from meta-analysis of studies of prophylaxis

pastes containing fluoride on permanent teeth (DMFS)

38

Table 12. Summary of standardized mean differences from meta-analysis and individual studies of

prophylaxis pastes containing fluoride

Outcome Measures


Number of participants



Individual study results of primary teeth data

defs increment, cavitated lesions

1 CCT83 40 0.14 [-0.48, 0.76]

Meta-Analysis results of permanent teeth data

DMFS increment, cavitated lesions

3 RCT78-80 and 2 CCT81, 82

2,297 -0.08 [-0.18, 0.02]

Notes:* RCT = randomized controlled trial; CCT = controlled clinical trial (non-randomized)

Evidence statements

The panel concluded with low certainty that there is no benefit from prophylaxis paste containing

fluoride application for 4 minutes twice per year for caries prevention in the primary teeth of 3-5-year-

olds. This statement is based on one small study of 40 participants with a high bias score.

The panel concluded with moderate certainty that there is no benefit from prophylaxis paste containing

fluoride application for 4 minutes twice per year for caries prevention in the permanent teeth of 8-16-

year-olds. This statement is based on meta-analysis of six studies with moderate-to-high bias scores including

almost 2,300 participants that showed low statistical heterogeneity (I2=35%) but inconsistent beneficial effects.

No studies were identified that tested fluoride prophylaxis pastes on adult populations for caries preventive

effect.

Evidence profiles: prophylaxis pastes containing fluoride



Benefit: No



Strength of clinical recommendation: Expert opinion against use Permanent teeth (children):


Benefit: No



Strength of clinical recommendation: Against

39

Permanent teeth – coronal caries (adults):





Strength of clinical recommendation: Expert opinion against use Permanent teeth - root caries (adults):


Benefit: Unknown




40

Is prophylaxis prior to professional application of topical fluoride necessary?


The panel identified two randomized84-86 and one non-randomized 87 clinical trials to assess whether

prophylaxis prior to professional application of topical fluoride impacts efficacy. All studies were of North

American children from 6-14 years of age at baseline. All studies reported data on permanent teeth, and one84

also reported data on primary teeth. All studies reported results on prophylaxis prior to APF gel (1.23%

fluoride) application.

The study characteristics, bias scores, and the extracted outcomes data are presented in Tables P through R

in Appendix 4. Two of the studies were judged to have bias scores of 3 and 685-87 and the other84 was 7. These

judgments of quality were primarily driven by lack of randomization; and if randomized, lack of reporting of the

randomization procedure, allocation concealment, blinding, and use of intention-to-treat analysis.

The panel combined the results on permanent teeth in a meta-analysis as shown in Fig. 8. Table 13

summarizes the standardized mean differences for both the primary (one study) and permanent (3 studies)

teeth.

Figure 8. Summary of standardized mean differences from meta-analysis of studies of prophylaxis

prior to professional application of APF gel (1.23% fluoride) on permanent teeth (DMFS)

41

Table 13. Summary of standardized mean differences from meta-analysis and individual studies of prophylaxis prior to professional application of APF gel (1.23% fluoride)

Outcomes Measure





Individual study results of primary teeth data

defs increment, cavitated lesions

1 RCT84 86 0.03 [-0.39, 0.46]

Meta-Analysis results of permanent teeth data

DMFS increment, cavitated lesions

2 RCT84-86 and 1 CCT87

1,363 0.00 [-0.11, 0.11]


Evidence statements

The panel concluded with low certainty that there is no benefit from conducting a prophylaxis prior to

APF gel (1.23% fluoride) application for caries prevention in primary teeth of children. This statement is

based on one small study of 86 participants with moderate bias score.

The panel concluded with moderate certainty that there is no benefit from conducting a prophylaxis prior

to APF gel (1.23% fluoride) application for caries prevention in the permanent teeth of 9-14-year-old

children. This statement is based on meta-analysis of three studies with moderate-to-high bias scores

including over 1,300 participants, consistent results, and no statistical heterogeneity (I2=0).

No studies were identified that tested prophylaxis prior to professional application of topical fluoride on adult

populations for caries preventive effect.

Evidence profiles: Prophylaxis prior to APF gel (1.23% fluoride) application



Benefit: No

Adverse events or harms: No harms noted


Strength of clinical recommendation: Expert opinion (not necessary) Permanent teeth (children):


Benefit: No



Strength of clinical recommendation: Against (not necessary)

42

Permanent teeth – coronal caries (adults):


Benefit: Unknown, but extrapolated from permanent teeth of children data (no benefit)



Strength of clinical recommendation: Expert opinion (not necessary) Permanent teeth - root caries (adults):


Benefit: Unknown




43

Prescription-strength, home-use (0.5% fluoride) gel/paste agents


The panel reviewed the data for prescription-strength, home-use (0.5% fluoride) gels and pastes together. The

primary difference between gels and pastes is that pastes contain a small amount of an abrasive component.

The panel noted that only one study88 evaluated prescription-strength fluoride paste or gel (in this case it was

paste) in an unsupervised home environment, rather than by professional application in trays or with floss or in

a supervised school setting.

The panel identified eight randomized88-97 and one non-randomized 98 clinical trials meeting inclusion criteria on

prescription-strength (0.5% fluoride) paste or gel for home use. Six of the studies88, 91-95, 97, 98 were on

permanent teeth, one89 was on root caries, and two93, 94, 96 were on primary teeth.

The comparison group for all studies was either placebo, 0.125-0.145% fluoride paste, or no treatment. The

baseline age range of children was 2 to 15 for most of the studies, with one study including participants over

75.89 The studies were performed in Denmark, French Polynesia, Netherlands, Sweden, and the United States.

The study characteristics, bias scores, and the extracted outcomes data are presented in Appendix 4, Tables S

through U for the paste studies and V through X for gel studies. The bias scores of the studies ranged from 2

to 10.

Both meta-analyses (Figure 9 for primary teeth and Figure 10 for permanent teeth) show a statistically

significant reduction of dental caries with prescription strength 0.5% F paste or gel compared to no treatment,

placebo, or 0.125-0.145% fluoride paste.

Table 14 summarizes the standardized mean differences from all the studies, grouped into those generated via

meta-analysis and individual studies not included in the meta-analysis. The reasons that the individual studies

could not be included in the meta-analysis include data reported as DMFT98 and root caries data reported as

the number of new caries lesions89.

44

Figure 9. Standardized mean differences from meta-analysis of studies of prescription-strength (0.5% fluoride) paste or gel on primary teeth [d(e/m)fs]

Figure 10. Standardized mean differences from meta-analysis of studies of prescription-strength (0.5% fluoride) paste or gel on permanent teeth [D(M)FS]

Table 14. Summary of standardized mean differences from individual studies on prescription-strength (0.5% fluoride) paste or gel

Outcome Measures






d(e/m)fs increment 2 RCT93, 94, 96 766 -0.15 [-0.30, -0.01]

D(M)FS incidence or increment

6 RCT88, 90-9292,

9395, 97 2,669 -0.33 [-0.55, -0.12]

Individual study results:

DMFT prevalence 1 CCT98 207 -0.45 [-0.75, -0.15]

New root caries lesions

1 RCT89 138 N/A**


**Data reported as number of new lesions. For 0.5% paste, there were 18 new active lesions, and for the 0.145% control, there were 41 new active lesions. This was reported to be a statistically significant reduction at p<0.02. N/A=not applicable.

Evidence statements

Much of the data on these products are the result of supervised clinical trials where the product was

administered using tray applicators. Currently, these products are often used at home and applied with a tooth

45

brush. As currently used, there are no studies to support or refute the effect of 0.5% fluoride (home use gels or

drops) for caries prevention, and only one study’s protocol was unsupervised use.88 There are also no studies

directly comparing gels and pastes. Because there are little data on these products as they are currently used

and there are varied results for prescription-strength (0.5% fluoride), home-use products, the panel was limited

in their certainty with the body of evidence.

The panel concluded with low certainty that there is a benefit of prescription-strength (0.5% fluoride)

paste or gel application twice daily for caries prevention in the primary teeth. This statement is based on

meta-analysis of 776 participants in two studies, one with a low bias score and one with a high bias score, with

no statistical heterogeneity (I2=0%), but some inconsistency.


paste or gel application twice daily for caries prevention in the permanent teeth of 9-16 year olds. This

statement is based on meta-analysis of six studies with a range of low to high bias scores and showing

statistical heterogeneity (I2=86%) that included 2,669 participants.


paste or gel application twice daily in preventing root caries in adults. This statement is based on one

study with a high bias score including 138 participants.

The panel identified no studies on the effect of prescription-strength (0.5% fluoride), home-use products on

caries prevention in the permanent teeth of adults between the ages of 18 and 75.

Evidence profiles: Prescription-strength, home-use (0.5% fluoride) gel/paste agents



Benefit: Yes (smaller caries increment or incidence with topical fluoride use). o SMD=-0.15 [-0.30, -0.01] o PF=0.19 o NNT for control rate of 1 dmfs per year = 5



Strength of clinical recommendation: Expert opinion against use. Note that depending on individual patient circumstances, benefits could outweigh potential harms.





46


Strength of clinical recommendation: Expert opinion for use Permanent teeth – coronal caries (adults):







Benefit: Yes (fewer new active lesions with topical fluoride use). o Benefit assessment based on data other than caries increment and calculations of PF, NNT,

MD not possible




47

Prescription-strength, home-use (0.09% fluoride) mouthrinse


The panel identified ten randomized99-110 and two non-randomized 111, 112 clinical trials that evaluated

prescription-strength (0.09% fluoride) mouthrinse applications with daily, weekly, or biweekly (every 2 weeks)

applications. The majority of the studies compared the intervention to placebo mouthrinses, although some

compared the intervention to no treatment107, 111 or oral hygiene instruction (OHI) and prophylaxis101. All studies

were conducted on permanent teeth.

The study characteristics, bias scores, and the extracted outcomes data are presented in Tables Y through AA

in Appendix 4. All studies but one109 were conducted in school age children from 5 to 12 years of age. No adult

populations were studied except long-term-care elders (mean age 83 years) in one study109. In most studies,

fluoride rinsing was supervised by the teacher. In only one study110 were children enrolled based on their caries

risk status. Four of the studies were conducted in the United States. The panel judged the bias scores of the

included studies to range from 3 to 7 (high to moderate risk of bias).

The panel combined the results of eight of the studies through a meta-analysis that was subdivided by

frequency of application. Four studies were excluded from the meta-analysis because of clinical heterogeneity

(the participants were long-term-care elders109) and non-comparable outcomes measures (DMFT

prevalence110, DMFS prevalence108, and DMFT increment112). Figure 11 presents the results of the meta-

analysis.

48

Figure 11. Standardized mean differences from meta-analysis of prescription-strength (0.09% fluoride)

mouthrinse studies subgrouped by frequency of use on permanent teeth [D(M)FS]

Notes: 1) Heifetz-mean data are weighted averages of data from Examiners 1 and 2 and the number of control subjects is divided in half to account for two subgroups; 2) Driscoll-mean data are weighted averages of data from Examiners 1 and 2, SD imputed using Cochrane equation, and the number of control subjects is divided in half to account for two subgroups; 3) Ringelberg-number of control subjects is divided in half to account for two subgroups; and 4) Chikte and Torell – not adjusted for clustering in this figure because ICCs are not known, but adjustment at ICC=0.1: -0.22 [-0.30, -0.15], I

2=0%;

at ICC=0.2: -0.22 [-0.30, -0.14], I2=0%.

The meta-analysis of studies that reported surface-level caries increment in permanent teeth (Figure 11)

indicated that there is a statistically significant reduction in caries with the use of prescription strength fluoride

mouthrinse compared to placebo, no treatment, or OHI and prophylaxis. By frequency of use, daily and

weekly rinsing showed statistically significant effects, while biweekly rinsing did not.

Table 15 summarizes the SMDs for all the trials. The first two rows present the results from meta-analysis,

while the bottom five rows present the individual-trial results. With respect to the individual trials, prescription-

strength fluoride mouthrinse was shown to have a statistically significant effect on caries increment when

measured by DMFS prevalence108 and DMFT increment112. One study110 reported no statistically significant

effect of mouthrinse on DMFT prevalence using a biweekly rinsing protocol. In addition, one study109 showed a

49

statistically significant effect of daily rinsing on root caries increment for long-term care elders, while there was

no statistically significant effect on coronal caries.

Table 15. Summary of standardized mean differences (SMD) meta-analysis of prescription-strength (0.09% fluoride) mouthrinse studies and for individual studies not included in the meta-analysis.

Outcome Measures Number

and type* of studies





D(M)FS, increment, daily, weekly and biweekly rinsing

7 RCT99-107 / 1 CCT111

4,374 -0.26 [-0.40, -0.13]

D(M)FS, increment, daily and weekly

rinsing only

5 RCT99-104,

106 / 1 CCT111

3,687 -0.20 [-0.27, -0.12]

Individual trial results:

DMFT prevalence [biweekly rinsing]

1 RCT110 273 0.17 [-0.08,0.41]

DMFS prevalence [weekly rinsing]

1 RCT108 377 -0.57 [-0.77, -0.36]

DMFT increment [biweekly rinsing]

1 CCT112 152 -0.38 [-0.70, -0.06]

Root caries increment, daily rinsing, long-term-care elders

1 RCT109 75 -0.54 [ -1.01, -0.08]

Coronal caries increment, daily

rinsing, long-term-care elders

1 RCT109 75 -0.16 [-0.62, 0.29]

Notes: *RCT = randomized controlled trial; CCT = controlled clinical trial (non-randomized); **Using non-cluster adjusted participant numbers

Evidence statements

The panel concluded with moderate certainty that there is a benefit of using prescription-strength (0.09%

fluoride) mouthrinse daily or weekly for caries prevention in permanent teeth among children aged 5-

12 years. This statement was based on meta-analysis of six moderate-to-high-risk-of-bias studies with over

3,600 participants; overall, these studies showed a consistent preventive effect and low statistical

heterogeneity (I2 = 17%).

The panel concluded with low certainty that there is a benefit of using prescription-strength (0.09%

fluoride) mouthrinse for root caries prevention among elders living in long-term-care facilities. This

statement is based on one study of 75 participants at high risk of bias showing a benefit of daily use of

prescription-strength (0.09% fluoride) mouthrinse to prevent root caries in an elderly population.

50

Finally, the panel identified no studies on prescription-strength (0.09% fluoride) mouthrinse in primary teeth or

in coronal caries of adults that met inclusion criteria.

Evidence profiles: Prescription-strength, home-use (0.09% fluoride) mouthrinse



Benefit: Unknown

Adverse events or harms: Potential risk for nausea, vomiting, and dental fluorosis, if excessive material swallowed

Benefit-harm assessment (Net benefit rating): Potential harms could outweigh unknown benefits














Benefit: Yes (smaller caries increment or incidence with topical fluoride use). o SMD=-0.54 [ -1.01, -0.08] o PF=0.48 o NNT for control rate of 1 DMFS per year = 2




51

Stannous fluoride 1

Although the literature search included the search term “stannous fluoride”, no studies were found that used 2

prescription-strength concentration. Oral health providers often dispense or prescribe stannous fluoride 3

products, however, the fluoride concentration of these products is 0.1%, which is an over-the-counter 4

concentration and comparable to that in fluoride dentifrice. 5

Erupting teeth 6

Several trials52, 55, 79, 81, 104, 105, 111-113 utilizing various forms of topical fluoride agents reported results on erupting 7

teeth. The data were presented such that they could not be meaningfully aggregated. However, taken as a 8

whole, the data suggest a consistent benefit for use of fluoride varnish, rinse, and gel while teeth are erupting, 9

but due to methodological heterogeneity, it is impossible to estimate the effect. Additional studies are needed 10

to clarify these relationships. 11

Systematic review conclusions 12

Based on the studies that matched the inclusion criteria (Table 2 and Figure 1), the panel concluded that some 13

professionally-applied and prescription-strength topical fluoride agents are efficacious in preventing and 14

controlling tooth decay. These products include 2.26% fluoride varnishes, 1.23% fluoride gels, prescription-15

strength, home-use 0.5% fluoride gels/pastes, and prescription-strength, home-use 0.09% fluoride 16

mouthrinses. The panel did not find that 0.1% fluoride varnishes or prophylaxis pastes containing fluoride were 17

efficacious in preventing tooth decay and found insufficient evidence on 1.23% fluoride foams. Efficacious 18

means that the product is capable of preventing new carious lesions under the controlled setting of a clinical 19

trial. 20

21

52

Limitations

Regarding the evidence

The panel noted several limitations to the literature on topical fluoride for caries prevention.

1. Fluoride exposures. Most of the literature is from a time period prior to the fluoride exposures

(toothpastes, fluoridated water) occurring regularly in most areas in the U.S. today. Therefore, the effect

that was found when the background fluoride exposure was lower may not be the same as (and

probably is higher than) in current times when there are much greater exposures to multiple sources of

fluoride, such as toothpaste and fluoridated water. This means that the effects reported in the studies

may be overestimated for the current environment.

2. Study design, quality, and reporting. The time period also impacts the current assessment of the quality

of studies. Standards concerning clinical research in medicine and dentistry have been refined over the

past 10-15 years to minimize bias and increase transparency. Reporting methods were less refined,

leading to uncertainty regarding the conduct of the trials. For example, the reporting of appropriate

methods of randomization, sample allocation concealment, accounting for losses to follow-up, and lack

of intention-to-treat analyses typically were lacking. Studies not using an intention-to-treat analysis tend

to overestimate the magnitude of effect, whereas studies with other types of bias listed in Table 3 can

overestimate, underestimate, or have no effect on the magnitude of effect.

3. Outcomes measures. The panel identified caries incidence, arrest and reversal as three outcomes

worthy of assessment. Unfortunately, the caries outcomes reported in most trials did not permit the

panel to determine the effects of these agents on arrest or reversal (remineralization) of caries.

Similarly, the effect of topical fluorides on erupting teeth could not be assessed in a standardized

manner.

4. Patient characteristics. The panel found that available study findings provided limited information about

the caries risk status of participants. Furthermore, although conclusions were reported in the literature

specific to various age groups, these groupings do not represent biologically or behaviorally distinct

populations. Therefore, to make meaningful recommendations, the panel extrapolated the evidence to

standardized age ranges. Lastly, there were very few data regarding adults over 18 years old.

53

Regarding this systematic review

Further, this systematic review contains a number of potentially important limitations:

1. Publication bias. The competitive environment in which clinical trials are financed and conducted, as

well as the non-reporting of negative results by some investigators or publications, fosters publication

bias.114 There were not enough studies for an assessment of publication bias by visual inspection of a

funnel plot.

2. The panel attempted to capture all available evidence from controlled studies listed in only two

databases, namely PubMed and Cochrane, and included only studies published in English. Articles

published in other languages could have contributed additional data that were not considered in this

review.

3. Notwithstanding that randomized controlled clinical trials are considered the gold standard for

therapeutic interventions, in light of the paucity of such literature, the panel also considered non-

randomized studies.

Future research The panel recommends that multiple well-designed, appropriately powered, placebo-controlled RCT’s following

the Consolidated Standards of Reporting Trials (CONSORT) guidelines115 be conducted in the U.S. with

standardized reporting by age, dentition, and caries risk status. Standard methodologies for caries and fluoride

randomized controlled trials should be developed. The panel recommends that future trials be registered with

clinicaltrials.gov or equivalent registries. Specific areas of research recommendations are listed as follows:

1. Mechanisms of fluoride action and effects. Research is needed on various topical fluorides as to their

mechanism of action and caries-preventive effects when in use at the current level of background

fluoride exposure (fluoridated water and fluoride toothpaste) in the U.S. Fluoride strategies to induce

arrest or reversal of caries progression, as well as their specific effect on erupting teeth, are also

needed.

2. Populations. Research is needed concerning the following subpopulations: a) adults, between 18 and

65; b) high risk adults older than 65 (including people living in long-term-care facilities); c) extremely

54

high risk children and adults; d) U.S. specific populations; e) special needs populations (e.g., cognitive

disabilities, compromised self-care abilities, physical disabilities); and f) populations with chronic

disease (such as Sjögrens syndrome). Comparative effectiveness studies of different fluoride strategies

in these populations are also lacking. Lastly, studies of strategies to manage xerostomia-induced

coronal and root caries are needed.

3. Products and usage. Research is needed concerning the effectiveness and risks of specific products in

the following areas: a) self-applied, prescription-strength, home-use fluoride gels/toothpastes/drops; b)

2% NaF professionally-applied gel; c) alternative delivery systems, such as foam; d) optimal application

frequencies for fluoride varnish and gels; e) 1 minute application of APF gel; and f) combinations of

products (home-use and professionally-applied).

4. Measurement and outcomes. Development of measurements to evaluate caries arrest and reversal are

needed.

5. Economics. Caries prevention and economic benefit of topical fluoride in different risk populations.

6. Dissemination and implementation. Research on the best ways to help practitioners incorporate clinical

recommendations into practice.

55

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58

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79. DePaola PF, Mellberg JR. Caries experience and fluoride uptake in children receiving semiannual prophylaxes with an acidulated phosphate fluoride paste. J Am Dent Assoc 1973;87(1):155-9.

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82. Horowitz HS, Lucye HS. A clinical study of stannous fluoride in a prophylaxis paste and as a solution. J Oral Ther Pharmacol 1966;3(1):17-25.

83. Schutze HJ, Forrester DJ, Balis SB. Evaluation of a fluoride prophylaxis paste in a fluoridated community. J Canad Dent Assn 1974(10):675-83.

84. Johnston DW, Lewis DW. Three-year randomized trial of professionally applied topical fluoride gel comparing annual and biannual applications with/without prior prophylaxis. Caries Res 1995;29(5):331-6.

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87. Houpt M, Koenigsberg S, Shey Z. The effect of prior toothcleaning on the efficacy of topical fluoride treatment. Two-year results. Clin Prev Dent 1983;5(4):8-10.

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91. Truin GJ, van 't Hof MA. Professionally applied fluoride gel in low-caries 10.5-year-olds. J Dent Res 2005;84(5):418-21.

59

92. Truin GJ, van't Hof M. The effect of fluoride gel on incipient carious lesions in a low-caries child population. Community Dent Oral Epidemiol 2007;35(4):250-4.

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94. van Rijkom HM, Truin GJ, van 't Hof MA. Caries-inhibiting effect of professional fluoride gel application in low-caries children initially aged 4.5-6.5 years. Caries Res 2004;38(2):115-23.

95. Englander HR, Keyes PH, Gestwicki M, Sultz HA. Clinical anticaries effect of repeated topical sodium fluoride applications by mouthpieces. JADA 1967;75:638-44.

96. Englander HR, Mellberg JR, Engler WO. Observations on dental caries in primary teeth after frequent fluoride toplications in a program involving other preventives. J Dent Res 1978;57(9-10):855-60.

97. Englander HR, Sherrill LT, Miller BG, et al. Incremental rates of dental caries after repeated topical sodium fluoride applications in children with lifelong consumption of fluoridated water. J Am Dent Assoc 1971;82(2):354-8.

98. Cutress T, Howell PT, Finidori C, Abdullah F. Caries preventive effect of high fluoride and xylitol containing dentifrices. ASDC J Dent Child 1992;59(4):313-8.

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100. Driscoll WS, Swango PA, Horowitz AM, Kingman A. Caries-preventive effects of daily and weekly fluoride mouthrinsing in a fluoridated community: final results after 30 months. J Am Dent Assoc 1982;105(6):1010-3.

101. Craig EW, Suckling GW, Pearce EI. The effect of a preventive programme on dental plaque and caries in school children. N Z Dent J 1981;77(349):89-93.

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107. Torell P. Two-year clinical tests with different methods of local caries-preventive fluorine application in Swedish school-children. Acta Odontol Scand 1965;23:287-322.

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60

115. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010;152(11):726-32.

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117. Englander HR, Keyes PH, Gestwicki M, Sultz HA. Clinical anticaries effect of repeated topical sodium fluoride applications by mouthpieces. J Am Dent Assoc 1967;75(3):638-44.

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61

Appendix 1 – Clinical Recommendations – detailed presentation

Topical Fluoride Agent

Age Group or Dentition Affected

Younger than 6 Years (Primary teeth)

6-18 Years (Mixed dentition)

Older than 18 Years (Permanent Teeth)

Adult Root caries

Varnish, 2.26% fluoride

Every 3 to 6 months (In Favor)

Every 3 to 6 months (In Favor)

Every 3 to 6 months (Expert Opinion For)

Every 3 to 6 months (Expert opinion For)

Varnish, 0.1% fluoride Not recommended

(Against) Not recommended

(Expert Opinion Against) Not recommended

(Expert Opinion Against) Panel unable to make

recommendation

Professionally-applied 1.23% fluoride (APF) gel

Not recommended (Expert Opinion Against)

4‡ minutes every 3-6

months (In Favor)

4‡ minutes every 3 to 6

months (Expert Opinion For)

4‡ minutes every 3 to 6

months (Expert Opinion For)

Prophylaxis prior to 1.23% fluoride (APF) gel application

Not necessary for caries prevention

(Expert Opinion Against)

Not necessary for caries prevention (Against)

Not necessary for caries prevention


Panel unable to make recommendation

Fluoride foam (1.23%

fluoride as APF) Not recommended



(Expert Opinion Against) Panel unable to make

recommendation

Prophylaxis paste containing fluoride

Not recommended for caries prevention



(Against)



Panel unable to make recommendation

Prescription-strength (0.5% fluoride), home-use fluoride products (gel, paste)


Twice daily (Expert Opinion For)



Mouthrinse, 0.09% fluoride


At least weekly (In Favor)

At least weekly (Expert Opinion For)

Daily (Expert Opinion For)

‡No studies tested APF gel for less than 4 minutes.

Table cell color legend.

62

Appendix 2 – Literature searches Primary search:

((DENTAL CARIES OR DENTAL CARIES ACTIVITY TESTS OR DENTAL CARIES

SUSCEPTIBILITY OR remineralisation OR demineralization OR remineralize OR remineralise

OR demineralize OR demineralise OR Tooth Demineralization OR tooth remineralization or

white spot) AND ("fluorides"[MeSH Terms] OR "fluorides"[All Fields] OR "fluoride"[All Fields])

OR APF[All Fields] OR (("silver"[MeSH Terms] OR "silver"[All Fields]) AND ("diamines"[MeSH

Terms] OR "diamines"[All Fields] OR "diamine"[All Fields])) OR ("tin fluorides"[MeSH Terms] OR

("tin"[All Fields] AND "fluorides"[All Fields]) OR "tin fluorides"[All Fields] OR ("stannous"[All

Fields] AND "fluoride"[All Fields]) OR "stannous fluoride"[All Fields]) OR (ACIDULATED[All

Fields] AND ("phosphates"[MeSH Terms] OR "phosphates"[All Fields] OR "phosphate"[All

Fields])) OR ("sodium fluoride"[MeSH Terms] OR ("sodium"[All Fields] AND "fluoride"[All Fields])

OR "sodium fluoride"[All Fields])) NOT (Review OR dentifrice OR in vitro OR in situ) LIMITS:

Humans, English

Secondary search (to identify dentifrice trials that also evaluated other agents of interest)

((DENTAL CARIES OR DENTAL CARIES ACTIVITY TESTS OR DENTAL CARIES

SUSCEPTIBILITY OR remineralisation OR demineralization OR remineralize OR remineralise

OR demineralize OR demineralise OR Tooth Demineralization OR tooth remineralization or

white spot) AND ("fluorides"[MeSH Terms] OR "fluorides"[All Fields] OR "fluoride"[All Fields])

OR APF[All Fields] OR (("silver"[MeSH Terms] OR "silver"[All Fields]) AND ("diamines"[MeSH

Terms] OR "diamines"[All Fields] OR "diamine"[All Fields])) OR ("tin fluorides"[MeSH Terms] OR

("tin"[All Fields] AND "fluorides"[All Fields]) OR "tin fluorides"[All Fields] OR ("stannous"[All

Fields] AND "fluoride"[All Fields]) OR "stannous fluoride"[All Fields]) OR (acidulated[All Fields]

AND ("phosphates"[MeSH Terms] OR "phosphates"[All Fields] OR "phosphate"[All Fields])) OR

("sodium fluoride"[MeSH Terms] OR ("sodium"[All Fields] AND "fluoride"[All Fields]) OR "sodium

fluoride"[All Fields]) AND (mouthwashes OR varnish* OR foam OR lacquer* OR laker* OR

lacker* OR lakk* laquer* OR duraphat OR fluor protector* flor* protector* OR gel* OR tray OR

paste* OR prophyla* OR mouthrins* OR mouth rins* OR rins* OR mouthwash* OR mouth wash*

mouth* rins* OR mouth* wash*)) Limits: Humans, English

Tertiary search (to identify trials that evaluated 5000ppm toothpaste) Limits: Humans, English

("Dentifrices"[Mesh]) AND ("fluorides"[MeSH Terms] OR "fluorides"[All Fields] OR "fluoride"[All

Fields]) AND 5000

63

Cochrane search strategy conducted March 4, 2011:

systematic[sb] AND ((DENTAL CARIES OR DENTAL CARIES ACTIVITY TESTS OR DENTAL CARIES

SUSCEPTIBILITY OR DMF* OR reminerali* OR deminerali* OR Tooth Demineralization OR tooth

remineralization or white spot) AND (FLUORIDE OR APF OR SILVER DIAMINE OR STANNOUS

FLUORIDE OR ACIDULATED PHOSPHATE OR SODIUM FLUORIDE))

64

Appendix 3 – Excluded studies at full-text stage

Citation Reason For

Exclusion

Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in

arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70.

Lo EC, Chu CH, Lin HC. A community-based caries control program for pre-school children using

topical fluorides: 18-month results. J Dent Res. 2001 Dec;80(12):2071-4.

Only arrests data.

Frostell G, Birkhed D, Edwardsson S, Goldberg P, Petersson LG, Priwe C, Winholt AS. Effect of

partial substitution of invert sugar for sucrose in combination with Duraphat treatment on caries

development in preschool children: the Malmö Study. Caries Res. 1991;25(4):304-10.

Study primarily

about the effect of

sugar and not

designed to test

the effect of

Duraphat; too

many data

transformations

necessary to

account for the

non-sugar groups;

concerns for

validity if use only

the non-sugar

data.

Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M.

Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of

schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4.

SDF versus no varnish; Not available in U.S.

Yee R, Holmgren C, Mulder J, Lama D, Walker D, van Palenstein Helderman W. Efficacy of silver

diamine fluoride for Arresting Caries Treatment. J Dent Res. 2009 Jul;88(7):644-7.

Various

concentrations;

Not available in

U.S.

Muhler JC, Spear LB Jr, Bixler D, Stookey GK. The arrestment of incipient dental caries in adults

after the use of three different forms of SnF2 therapy: results after 30 months. J Am Dent Assoc.

1967 Dec;75(6):1402-6.

Multiple

interventions.

Long JG. Self-applied fluoride paste; effect on dental caries. J Public Health Dent. 1972

Summer;32(3):161-4.

Woodhouse AD. A longitudinal study of the effectiveness of self applied 10 per cent stannous

fluoride paste for secondary school children. Aust Dent J. 1978 Oct;23(5):422-8.

Self applied

prophy paste.

Self applied.

Horowitz H, Bixler D. The effect of self-applied SnF2-ZrSIO4 prophylactic paste on dental caries:

Santa Clara County, Calif. J Am Dent Assoc. 1976 92(2).

Self applied.

Gish CW, Mercer VH, Stookey GK, Dahl LO. Self-application of fluoride as a community preventive

measure: rationale, procedures, and three-year results. J Am Dent Assoc. 1975 Feb;90(2):388-97.

Self applied.

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Chu%20CH%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lo%20EC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lin%20HC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed/12407092


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lo%20EC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Chu%20CH%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lin%20HC%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Frostell%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Birkhed%20D%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Edwardsson%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Goldberg%20P%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Petersson%20LG%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Priwe%20C%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Winholt%20AS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Llodra%20JC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Rodriguez%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ferrer%20B%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Menardia%20V%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ramos%20T%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Morato%20M%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Yee%20R%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Holmgren%20C%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mulder%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lama%20D%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Walker%20D%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22van%20Palenstein%20Helderman%20W%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Muhler%20JC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Spear%20LB%20Jr%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bixler%20D%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Stookey%20GK%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Long%20JG%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Woodhouse%20AD%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gish%20CW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mercer%20VH%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Dahl%20LO%22%5BAuthor%5D



65

Ruiken R, Truin GJ, König K, Vogels A, van 't Hof M. Clinical cariostatic effectiveness of a NaF rinse

in a low prevalence child population. Community Dent Oral Epidemiol. 1987 Apr;15(2):57-9.

No relevant

outcome reported.

Percentile of DFS

scores. No idea

what the control

group was. No

information on

allocation of

schools/participan

ts.

Zimmer S, Robke FJ, Roulet JF. Caries prevention with fluoride varnish in a socially deprived

community. Community Dent Oral Epidemiol. 1999 Apr;27(2):103-8.

Cohort study with

one school

starting the

varnish a year

after the other two

test schools.

Separate data not

available. Also

frequency of

application of

varnish different

between years.

Carlsson P, Struzycka I, Wierzbicka M, Iwanicka-Frankowska E, Bratthall D. Effect of a preventive

program on dental caries and mutans streptococci in Polish schoolchildren. Community Dent Oral

Epidemiol. 1988 Oct;16(5):253-7.

Multiple

interventions.

Källestål C. The effect of five years' implementation of caries-preventive methods in Swedish high-

risk adolescents. Caries Res. 2005 Jan-Feb;39(1):20-6.

Källestål C, Flinck A, Allebeck P, Holm AK, Wall S. Evaluation of caries preventive measures. Swed

Dent J. 2000;24(1-2):1-11.

Källestål C, Fjelddahl A. A four-year cohort study of caries and its risk factors in adolescents with

high and low risk at baseline. Swed Dent J. 2007;31(1):11-25.

No relevant

control group.

Varnish vs.

fluoride

toothpaste. No

other relevant

control group.

Ersin NK, Eden E, Eronat N, Totu FI, Ates M. Effectiveness of 2-year application of school-based

chlorhexidine varnish, sodium fluoride gel, and dental health education programs in high-risk

adolescents. Quintessence Int. 2008 Feb;39(2):e45-51.

No relevant

control group.

Powell LV, Persson RE, Kiyak HA, Hujoel PP. Caries prevention in a community-dwelling older

population. Caries Res. 1999 Sep-Oct;33(5):333-9.

No baseline data.

Peyron M, Matsson L, Birkhed D. Progression of approximal caries in primary molars and the effect

of Duraphat treatment. Scand J Dent Res. 1992 Dec;100(6):314-8.

Analysis of data

for a subset from

the Malmö study

which we have

excluded.

Badersten A, Egelberg J, Koch G. Effect of monthly prophylaxis on caries and gingivitis in

schoolchildren. Community Dent Oral Epidemiol. 1975 Feb;3(1):1-4.

Combination and

no relevant

control.

Clark DC, Robert G, Tessier C, Fréchette N, Le Blanc G, Boucher L, Maheux S, Le Blanc D. The

results after 20 months of a study testing the efficacy of a weekly fluoride mouthrinsing program. J

Public Health Dent. 1985 Fall;45(4):252-6.

Control arm had

co-intervention

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ruiken%20R%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Truin%20GJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22K%C3%B6nig%20K%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Vogels%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22van%20't%20Hof%20M%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Zimmer%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Robke%20FJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Roulet%20JF%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22K%C3%A4llest%C3%A5l%20C%22%5BAuthor%5D





http://www.ncbi.nlm.nih.gov/pubmed?term=%22Fjelddahl%20A%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ersin%20NK%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Eden%20E%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Eronat%20N%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Totu%20FI%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ates%20M%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Powell%20LV%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Persson%20RE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kiyak%20HA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hujoel%20PP%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Peyron%20M%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Matsson%20L%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Badersten%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Egelberg%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Koch%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Clark%20DC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Robert%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Tessier%20C%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Fr%C3%A9chette%20N%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Le%20Blanc%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Boucher%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Maheux%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Le%20Blanc%20D%22%5BAuthor%5D



66

Louw AJ, Carstens IL, Hartshorne JE, Blignaut RJ. Effectiveness of two school-based caries

preventive programmes. J Dent Assoc S Afr. 1995 Feb;50(2):43-9.

The baseline

between groups

was not

comparable. So

they threw out the

kids’ very high

caries in the test

group and then

compared the

groups.

Dreizen S, Brown LR, Daly TE, Drane JB. Prevention of xerostomia-related dental caries in

irradiated cancer patients. Journal of Dental Research. 1977 56(2).

Special

population

Toolson LB, Smith DE. A 2-year longitudinal study of overdenture patients. Part I: incidence and

control of caries on overdenture abutments. J Prosthet Dent. 1978 Nov;40(5):486-91.

Special case:

overdenture

abutments

DePaola PF, Soparkar P, Foley S, Bookstein F, Bakhos Y. Effect of high-concentration ammonium

and sodium fluoride rinses on dental caries in schoolchildren. Community Dent Oral Epidemiol.

1977 Jan;5(1):7-14.

Not prescription

strength

Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diamine fluoride on

incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009

Jan-Apr;76(1):28-33.

SDF versus

Toothbrushing.

Split mouth.

Zickert I, Lindvall AM, Axelsson P. Effect on caries and gingivitis of a preventive program based on

oral hygiene measures and fluoride application. Community Dent Oral Epidemiol. 1982

Dec;10(6):289-95.

Multiple

interventions.

Ekstrand K, Martignon S, Holm-Pedersen P. Development and evaluation of two root caries

controlling programmes for home-based frail people older than 75 years. Gerodontology. 2008. p.

67-75.

Duraphat applied

once a month

based on whether

there was active

lesion at the

monthly visit. Not

a periodic

treatment.

Subjects used F

toothpaste also.

For control group

participants were

asked to brush

twice a day with a

similar F

toothpaste.

Horowitz HS, Heifetz SB, McClendon BJ, et al. Evaluation of self administered prophylaxis and

supervised toothbrushing with acidulated phosphate fluoride. CARIES RES (BASEL). 1974 8(1) 39-

51.

Self-applied

1.23% APF with

brushing.

Wegner H. The clinical effect of application of fluoride varnish. Caries Res. 1976;10(4):318-20. No concurrent

control group.

Ripa LW, Leske GS, Varma A. Effect of mouthrinsing with a 0.2 per cent neutral NaF solution on the

deciduous dentition of first to third grade school children. Pediatr Dent. 1984 Jun;6(2):93-7.

No control group.

Petchel KA, Mello AF. A school fluoride mouthrinse program. J Sch Health. 1977 Nov;47(9):557-8.

Not a controlled

study.

Ripa LW, Leske G. Effect on the primary dentition of mouthrinsing with a 0.2 percent neutral NaF

solution: results from a demonstration program after four school years. Pediatr Dent. 1981

Dec;3(4):311-5.

Ripa LW, Leske G. Effect on the primary dentition of mouthrinsing with a 0.2 percent neutral NaF

solution: results from a demonstration program after three school years. Pediatr Dent. 1980

Sep;2(3):184-9.

No concurrent

control group.

Segreto VA, Jerman AC, Devlyn JE. Oral prophylaxis pellet: a stable stannous fluoride preparation.

Aeromed Rev. 1969 Jul;3:1-6.

Not a caries

study.

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Louw%20AJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Carstens%20IL%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hartshorne%20JE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Blignaut%20RJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Toolson%20LB%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Smith%20DE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22DePaola%20PF%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Soparkar%20P%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Foley%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bookstein%20F%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bakhos%20Y%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Braga%20MM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mendes%20FM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22De%20Benedetto%20MS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Imparato%20JC%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Zickert%20I%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lindvall%20AM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Axelsson%20P%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Wegner%20H%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ripa%20LW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Leske%20GS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Varma%20A%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Petchel%20KA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mello%20AF%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Leske%20G%22%5BAuthor%5D






http://www.ncbi.nlm.nih.gov/pubmed?term=%22Segreto%20VA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Jerman%20AC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Devlyn%20JE%22%5BAuthor%5D


67

Horowitz HS. Caries prevention and fluoride preparations. Symp Pharmacol Ther Toxicol Group.

1974 Mar 21:36-43.

Review.

Hamp SE, Lindhe J, Fornell J, Johansson LA, Karlsson R. Effect of a field program based on systematic

plaque control on caries and gingivitis in schoolchildren after 3 years.

Community Dent Oral Epidemiol. 1978 Jan;6(1):17-23.

Fluoride prophy

paste and rinse.

Composition of

prophy pastes

and treatments

varies between

the study years

and no

information on the

program for the

control kids.

Serra Pujol ME, Bosch Pou G, Bertrán Martí L, Jorba Vives M, González Svatetz CA, Agudo Trigueros A. Servei de Salut Escolar. IMS, Mataró.

Not English.

Hamp SE, Johansson LA. Dental prophylaxis for youths in their late teens. I. Clinical effect of different

preventive regimes on oral hygiene, gingivitis and dental caries. J Clin Periodontol.

1982 Jan;9(1):22-34.

Multiple

interventions vary

by year.

Nishino M, Yoshida S, Sobue S, Kato J, Nishida M. Effect of topically applied ammoniacal silver

fluoride on dental caries in children. J Osaka Univ Dent Sch. 1969 Sep;9:149-55.

No clinical

evaluation.

Xhemnica L, Sulo D, Rroço R, Hysi D. Fluoride varnish application: a new prophylactic method in Albania. Effect on enamel carious lesions in permanent dentition. Eur J Paediatr Dent. 2008 Jun;9(2):93-6.

Short term study

but they did report

cavitation.

However 6% NaF

and 6% CaF

varnish.

Ritter AV. Fluoride varnishes. J Esthet Restor Dent. 2003;15(4):256.

Johnson G, Almqvist H. Non-invasive management of superficial root caries lesions in disabled and

infirm patients. Gerodontology. 2003 Jul;20(1):9-14.

Multiple

interventions.

Lindhe J, Axelsson P. The effect of controlled oral hygiene and topical fluoride application on caries

and gingivitis in Swedish schoolchildren. Community Dent Oral Epidemiol. 1973 1(1)

Solution and

SMFP paste.

Weisz WS. The reduction of dental caries through use of a sodium fluoride mouthwash. J Am Dent Assoc. 1960 Apr;60:438-56.

Patients over 10 years, Case-control type analysis.

Houwink B, Dirks OB, Kwant GW. A nine-year study of topical application with stannous fluoride in identical twins and the caries experience five years after ending the applications. Caries Res. 1974;8(1):27-38.

SnF solution.

Roberts-Thomson KF, Slade GD, Bailie RS, Endean C, Simmons B, Leach AJ, Raye I, Morris PS. A comprehensive approach to health promotion for the reduction of dental caries in remote Indigenous Australian children: a clustered randomised controlled trial. Int Dent J. 2010 Jun;60(3 Suppl 2):245-9.

Multiple interventions.

Potter DE, Manwell MA, Dess R, Levine E, Tinanoff N. SnF2 as an adjunct to toothbrushing in an elderly institutionalized population. Spec Care Dentist. 1984 Sep-Oct;4(5):216-8.

0.4% SnF.

Fure S, Lingström P. Evaluation of different fluoride treatments of initial root carious lesions in vivo. Oral Health Prev Dent. 2009;7(2):147-54.

SnF Solution vs. Duraphat vs. Carosolv + Duraphat.

Ravald N, Birkhed D. Prediction of root caries in periodontally treated patients maintained with different fluoride programmes. Caries Res. 1992;26(6):450-8.

Duraphat vs. 0.05% Rinse vs. 0.4% SnF2 – OTC comparisons with Duraphat.

Cartwright HV, Lindahl RL, Bawden JW. Clinical findings on the effectiveness of stannous fluoride and acid phosphate fluoride as caries reducing agents in children. J Dent Child. 1968 Jan;35(1):36-40.

Solution. Teeth surfaces were kept wet with the fluoride solution for four minutes by frequenter-application.

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Horowitz%20HS%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hamp%20SE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lindhe%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Fornell%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Johansson%20LA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Karlsson%20R%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Serra%20Pujol%20ME%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bosch%20Pou%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bertr%C3%A1n%20Mart%C3%AD%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Jorba%20Vives%20M%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gonz%C3%A1lez%20Svatetz%20CA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Agudo%20Trigueros%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hamp%20SE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Johansson%20LA%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nishino%20M%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Yoshida%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Sobue%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kato%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nishida%20M%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Xhemnica%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Sulo%20D%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Rro%C3%A7o%20R%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hysi%20D%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ritter%20AV%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Johnson%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Almqvist%20H%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22WEISZ%20WS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Houwink%20B%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Dirks%20OB%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kwant%20GW%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Roberts-Thomson%20KF%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Slade%20GD%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bailie%20RS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Endean%20C%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Simmons%20B%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Leach%20AJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Raye%20I%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Morris%20PS%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Potter%20DE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Manwell%20MA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Dess%20R%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Levine%20E%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Tinanoff%20N%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Fure%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lingstr%C3%B6m%20P%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ravald%20N%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Cartwright%20HV%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lindahl%20RL%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bawden%20JW%22%5BAuthor%5D



68

Bijella MF, Bijella VT, Lopes ES, Bastos JR. Comparison of dental prophylaxis and toothbrushing prior to topical APF applications. Community Dent Oral Epidemiol. 1985 Aug;13(4):208-11.

Paper says APF solution but does not provide information on method of application. The control group did not get varnish and hence we cannot use it to answer the question on whether prior prophy is required.

Petersson LG, Magnusson K, Andersson H, Almquist B, Twetman S. Effect of quarterly treatments with a chlorhexidine and a fluoride varnish on approximal caries in caries-susceptible teenagers: a 3-year clinical study. Caries Res. 2000 Mar-Apr;34(2):140-3.

F vs. CHX.

Birkeland JM, Jorkjend L. Effect of mouth rinsing and toothbrushing with fluoride solutions on caries among Norwegian schoolchildren. Community Dent Oral Epidemiol. 1975 Sep;3(5):201-7.

Rinse vs. F toothpaste.

Stecksén-Blicks C, Renfors G, Oscarson ND, Vivaldi-Rodrigues G, Demito CF, Bowman SJ, Ramos AL. The effectiveness of a fluoride varnish in preventing the development of white spot lesions. World Journal of Orthodontics. 2006 7(2):138-44.

Split mouth.

Altenburger MJ, Schirrmeister JF, Wrbas KT, Klasser M, Hellwig E. Fluoride uptake and remineralisation of enamel lesions after weekly application of differently concentrated fluoride gels. Caries Res. 2008 42(4):312-8.

In situ.

Ferreira MA, Latorre Mdo R, Rodrigues CS, Lima KC. Effect of regular fluoride gel application on incipient carious lesions. Oral Health & Preventive Dentistry. 2005 3(3):141-9.

Short term WSL.

Willmot DR. White lesions after orthodontic treatment: does low fluoride make a difference? Journal of Orthodontics. 2004 31(3):235-42.

Toothpaste and mouthrinse used together – Combination.

Axelsson P, Lindhe J. Effect of fluoride on gingivitis and dental caries in a preventive program based on plaque control. Community Dent Oral Epidemiol. 1975 3(4).

SMFP.

Vivaldi-Rodrigues G, Demito CF, Bowman SJ, Ramos AL. The effectiveness of a fluoride varnish in preventing the development of white spot lesions. World Journal of Orthodontics. 2006 7(2):138-44.

Split mouth.

Ferreira JM, Aragão AK, Rosa AD, Sampaio FC, Menezes VA. Therapeutic effect of two fluoride varnishes on white spot lesions: a randomized clinical trial. Braz Oral Res. 2009 Oct-Dec;23(4):446-51.

Short-term WSL study.

de Amorim RG, Leal SC, Bezerra AC, de Amorim FP, de Toledo OA. Association of chlorhexidine and fluoride for plaque control and white spot lesion remineralization in primary dentition. Int J Paediatr Dent. 2008 Nov;18(6):446-51. Epub 2008 May 16.

Short Term WSL.

Gontijo L, Cruz Rde A, Brandão PR. Dental enamel around fixed orthodontic appliances after fluoride varnish application. Braz Dent J. 2007;18(1):49-53.

Split mouth.

Stecksén-Blicks C, Renfors G, Oscarson ND, Bergstrand F, Twetman S. Caries-preventive effectiveness of a fluoride varnish: a randomized controlled trial in adolescents with fixed orthodontic appliances. Caries Res. 2007;41(6):455-9. Epub 2007 Sep 7.

6 month WSL study in ortho patients.

Tranaeus S, Al-Khateeb S, Björkman S, Twetman S, Angmar-Månsson B. Application of quantitative light-induced fluorescence to monitor incipient lesions in caries-active children. A comparative study of remineralisation by fluoride varnish and professional cleaning. Eur J Oral Sci. 2001 Apr;109(2):71-5.

Short term QLF study.

Tewari A, Chawla HS, Gopalakrishnan NS. Acidulated phosphate fluoride--3 1/2 years clinical trial on the prevention of dental caries. J Indian Soc Pedod Prev Dent. 1986 Mar;4(1):15-24. Tewari A, Chawla HS, Reddy VV. Efficacy of acidulated phosphate fluoride in the prevention of dental caries--a 2 1/2 years study. J Indian Soc Pedod Prev Dent. 1983 Mar;1(1):20-7.

This paper describes the use of “APF” without stating exactly what the method of delivery is or what the concentration was. They use the word “painted” in the methods and in the discussion talk about other papers that have evaluated solution.

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bijella%20MF%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bijella%20VT%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lopes%20ES%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bastos%20JR%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Magnusson%20K%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Andersson%20H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Almquist%20B%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Twetman%20S%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Birkeland%20JM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Jorkjend%20L%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ferreira%20JM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Arag%C3%A3o%20AK%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Rosa%20AD%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Sampaio%20FC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Menezes%20VA%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22de%20Amorim%20RG%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Leal%20SC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bezerra%20AC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22de%20Amorim%20FP%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22de%20Toledo%20OA%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gontijo%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Cruz%20Rde%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Brand%C3%A3o%20PR%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Stecks%C3%A9n-Blicks%20C%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Renfors%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Oscarson%20ND%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bergstrand%20F%22%5BAuthor%5D





http://www.ncbi.nlm.nih.gov/pubmed?term=%22Tranaeus%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Al-Khateeb%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bj%C3%B6rkman%20S%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Angmar-M%C3%A5nsson%20B%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Tewari%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Chawla%20HS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gopalakrishnan%20NS%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Chawla%20HS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Reddy%20VV%22%5BAuthor%5D



69

Bordoni N, Bellagamba H, Doño R, Piovano S, Marcantoni M, Squassi A. Effect of self-brushing with acidulated phosphate fluoride (pH 5.6) on dental caries in children. Acta Odontol Latinoam. 1994-1995;8(2):17-25.

Not all the children were examined. Incomplete study.

Ogaard B, Rølla G, Arends J, ten Cate JM. Orthodontic appliances and enamel demineralization. Part 2. Prevention and treatment of lesions. Am J Orthod Dentofacial Orthop. 1988 Aug;94(2):123-8.

Short term white spot ortho study - 4 week follow up.

Szwejda LF. Fluorides in community programs: a study for four years of the cariostatic effects of prophylactic pastes, rinses, and applications of various fluorides. J Public Health Dent. 1972 Spring;32(2):110-8. Szwejda LF. Fluorides in community programs: results after four years of study of various agents topically applied by two technics. J Public Health Dent. 1971 Summer;31(3):166-76.

NaF and APF solution but interventions varied between study years for all groups.

Szwejda LF. Fluorides in community programs; a study of four years of various fluorides applied topically to the teeth of children in fluoridated communities. J Public Health Dent. 1972 Winter;32(1):25-33.

Not commercially available products

Hass R. Effectiveness of a single application of stannous fluoride after toothbrushing. J Am Dent Assoc. 1965 71(6).

8% SnF Solution applied with cotton applicators.

Wellock WD, Maitland A, Brudevold F. Caries increments, tooth discoloration, and state of oral hygiene in children given single annual applications of acid phosphate-fluoride and stannous fluoride. Arch Oral Biol. 1965 May-Jun;10(3):453-60.

8% SnF and APF solution applied with cotton applicators and teeth kept wet for 4 minutes.

Zahran M. Effect of topically applied acidulated phosphate fluoride on dental caries. Community Dent Oral Epidemiol. 1976 Nov;4(6):240-3.

APF Fluoride solution (2% NaF in 0.15M phosphoric acid, pH 3.2) applied with a cotton applicator.

McCombie F, Hole LW. Two year effect of supervised toothbrushing with an acidulated fluoride-phosphate solution. J Can Dent Assoc (Tor). 1966 Feb;32(2):89-93.

Phosphate fluoride solution. Kids dipped toothbrush in solution and brushed teeth.

Averill HM, Averill JE, Ritz AG. A 2-year comparison of three topical fluoride agents. J Am Dent Assoc. 1967 Apr;74(5):996-1001. Averill HM, Averill JE, Ritz AG, Little MF. A two-year comparison of three topical fluoride agents. Am J Public Health Nations Health. 1967 Sep;57(9):1627-34.

2% aqueous NaF, 4% SnF and 2% APH. All solution coated several times onto the tooth with cotton applicators.

Mercer VH, Muhler JC. Comparison of single topical applications of sodium fluoride and stannous fluoride. J Dent Res. 1972 Sep-Oct;51(5):1325-30.

Paper calls it Solution and does not describe method of application. 8% SnF, 4% SnF, 0.4% SnF and 2% NaF.

Hyde EJ. Caries-inhibiting action of three different topically-applied agents on incipient lesions in newly erupted teeth: results after 24 months. J Can Dent Assoc (Tor). 1973 Mar;39(3):189-93.

8% SnF Solution and “APF solution”. No indication of method of application.

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bordoni%20N%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bellagamba%20H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Do%C3%B1o%20R%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Piovano%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Marcantoni%20M%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Squassi%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ogaard%20B%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22R%C3%B8lla%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Arends%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22ten%20Cate%20JM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Szwejda%20LF%22%5BAuthor%5D









http://www.ncbi.nlm.nih.gov/pubmed?term=%22Wellock%20WD%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Maitland%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Brudevold%20F%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Zahran%20M%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22McCombie%20F%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hole%20LW%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Averill%20HM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Averill%20JE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ritz%20AG%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Averill%20HM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Averill%20JE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ritz%20AG%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Little%20MF%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mercer%20VH%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Muhler%20JC%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hyde%20EJ%22%5BAuthor%5D



70

Horowitz HS, Heifetz SB. Evaluation of topical applications of stannous fluoride to teeth of children born and reared in a fluoridated community: interim report. J Dent Child. 1967 Jul;34(4):290-5.

Horowitz HS, Heifetz SB. Evaluation of topical applications of stannous fluoride to teeth of children born and reared in a fluoridated community: final report. ASDC J Dent Child. 1969 Sep-Oct;36(5):355-61.

8% SnF and 10% SnF. The paper clearly calls these solutions although method of application is not specified. Powder mixed with water just prior to application. Applied according to method described by Dudding and Muhler.

Burgess RC, Kreutzer J. Caries, prophylaxis, and fluorides. Appl Ther. 1966 Sep;8(9):760-4. Review.

Toth K. The methods and results of caries prevention with fluorides in Hungary and in Eastern European countries. Rev Belge Med Dent. 1972;27(4):521-7.

Review.

Fleming TJ. Use of topical fluoride by patients receiving cancer therapy. Curr Probl Cancer. 1983 Apr;7(10):37-41.

Caries not outcome.

Powell KR, Barnard PD, Craig GG. Effect of stannous fluoride treatments on the progression of initial lesions in approximal surfaces of permanent posterior teeth. Journal of Dental Research. 1981;60(9): 1648-54.

Evaluated 10% SnF. Paper calls it Solution but does not describe method of application.

Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after two years. Pediatric Dentistry. 1987 Jun;9(2): 121-5.

Rinse vs. F tab.

Myers RE, Mitchell DL. Fluoride for the head and neck radiation patient. Mil Med. 1988 Aug;153(8):411-3.

Review.

Mallatt ME, Morris P. Is prophylaxis really necessary prior to the application of fluoride for the prevention of caries? J Indiana Dent Assoc. 2006 Fall;85(3):20-1.

Review.

Richards W. Improving the oral health of young children through an evidence-based approach. Community Dent Health. 2006 Jun;23(2):124-5.

Letter.

Worthington H, Clarkson J. Cochrane Oral Health Group. The evidence base for topical fluorides. Community Dent Health. 2003 Jun;20(2):74-6.

Editorial.

Tinanoff N. Caries management in children: decision-making and therapies. Compend Contin Educ Dent. 2002 Dec;23(12 Suppl):9-13.

Review.

Martin AP. Silver fluoride use. Aust Dent J. 1997 Feb;42(1):66-7. Letter.

Miller MC, Truhe TF. Preventive dentistry for pediatric patients. J Calif Dent Assoc. 1995 Feb;23(2):42-4.

Review.

[No authors listed]. Researchers investigate methods to prevent caries on roots and crowns. J Am Dent Assoc. 1992 Nov;123(11):22, 24.

Announcement.

Raadal M, Laegreid O, Laegreid KV, Hveem H, Wangen K. Evaluation of a routine for prevention and treatment of fissure caries in permanent first molars. Community Dent Oral Epidemiol. 1990 Apr;18(2):70-3.

Combined topical fluoride and sealant.

Mallatt ME, Christen A. Is a prophylaxis really necessary prior to topical fluoride therapy? J Indiana Dent Assoc. 1989 Jan-Feb;68(1):33-5.

Review.

Mellberg JR, Lass A, Petrou I. Inhibition of artificial caries lesion formation by APF and neutral NaF office gels. Am J Dent. 1988 Dec;1(6):255-7.

In vitro study.

Bohannan HM, Klein SP, Disney JA, Bell RM, Graves RC, Foch CB. A summary of the results of the National Preventive Dentistry Demonstration Program. J Can Dent Assoc. 1985 Jun;51(6):435-41.

Multiple Interventions.

Wei SH, Lau EW, Hattab FN. Time dependence of enamel fluoride acquisition from APF gels. II. In vivo study. Pediatr Dent. 1988 Sep;10(3):173-7.

Fluoride uptake study.

Tubert-Jeannin S, Riordan PJ. Association of caries experience in 12-year-old children in Heidelberg, Germany and Montpellier, France with different caries preventive measures. Community Dent Oral Epidemiol. 2003 Feb;31(1):75-6; author reply 77-8.

Letter.

Ripa LW. Caries prevention in children: the use of fluoride mouthrinses and pit and fissure sealants. N Y State Dent J. 1987 Feb;53(2):16-20.

Review.


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Heifetz%20SB%22%5BAuthor%5D







http://www.ncbi.nlm.nih.gov/pubmed?term=%22Burgess%20RC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kreutzer%20J%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Toth%20K%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Fleming%20TJ%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Myers%20RE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mitchell%20DL%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mallatt%20ME%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Morris%20P%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Richards%20W%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Worthington%20H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Clarkson%20J%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Martin%20AP%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Miller%20MC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Truhe%20TF%22%5BAuthor%5D





http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mallatt%20ME%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Christen%20A%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mellberg%20JR%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lass%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Petrou%20I%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bohannan%20HM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Klein%20SP%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Disney%20JA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bell%20RM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Graves%20RC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Foch%20CB%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Wei%20SH%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lau%20EW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hattab%20FN%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Tubert-Jeannin%20S%22%5BAuthor%5D

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71

Tewari A, Goyal A. Fluoride varnishes--a milestone discovery in the prevention of dental caries--I. J Indian Dent Assoc. 1986 Feb;58(2):55-6.

Review.

Billings RJ. Restoration of carious lesions of the root. Gerodontology. 1986 Spring;5(1):43-9.

Review.

Tewari A, Gauba K, Chandigarh PG. Fluoride. Critical appraisal of acidulated phosphate fluoride as a cariostatic agent. J Indian Dent Assoc. 1986 Jan;58(1):11-2.

Review.

Perry D, Newman MG. Uses of fluoride in dentistry. CDA J. 1985 Dec;13(12):31-6. Review.

Rossy R, Tinanoff N. Topical fluoride therapy. J Clin Orthod. 1985 Jul;19(7):524-6. Review.

Billings RJ, Brown LR, Kaster AG. Contemporary treatment strategies for root surface dental caries. Gerodontics. 1985 Feb;1(1):20-7.

No valid control group.

Clark DC, Hanley JA, Stamm JW, Weinstein PL. An empirically based system to estimate the effectiveness of caries-preventive agents. A comparison of the effectiveness estimates of APF gels and solutions, and fluoride varnishes. Caries Res. 1985;19(1):83-95.

Review.

Stamm JW, Bohannan HM, Graves RC, Disney JA. The efficiency of caries prevention with weekly fluoride mouthrinses. J Dent Educ. 1984 Nov;48(11):617-26.

Review.

Silverstone LM. The significance of remineralization in caries prevention. J Can Dent Assoc. 1984 Feb;50(2):157-67.

In vitro evaluation.

Vassilopoulou A, White GE. The effectiveness of a 0.4% stannous fluoride gel vs. a 0.1% stannous fluoride rinse on occlusal enamel. J Pedod. 1986 Winter;10(2):141-7.

Outcome not caries.

Holland T, O'Leary K, O'Mullane D. The effectiveness of a fortnightly mouthrinsing programme in the prevention of dental caries in school children. J Ir Dent Assoc. 1987;33(2-4):24-7.

Rinsing compared to fluoridated water.

McCall DR, Watkins TR, Stephen KW, Collins WJ, Smalls MJ. Fluoride ingestion following APF gel application. Br Dent J. 1983 Nov 19;155(10):333-6.

Safety study

Inaba D, Kawasaki K, Iijima Y, Taguchi N, Hayashida H, Yoshikawa T, Furugen R, Fukumoto E, Nishiyama T, Tanaka K, Takagi O. Enamel fluoride uptake from mouthrinse solutions with different NaF concentrations. Community Dent Oral Epidemiol. 2002 Aug;30(4):248-53.

Caries not an outcome.

Boyd CH, Boyd CM, Gallien GS Jr. A preliminary report: the effectiveness of 0.4% stannous fluoride on controlling dental caries. Ark Dent J. 1985 Dec;56(4):14-5.

Short term study and OTC.

Osterbrock NL. Fluoride mouthrinsing in Cincinnati elementary schools. Cincinnati Dent Soc Bull. 1983 Sep;52(7):20-1. Alacam T, Yilmaz T. In vivo remineralization of carious dentine treated with 10% solution of stannous fluoride. J Endod. 1983 Aug;9(8):313-5.

Review.

Sposato AL, Leske GS, Ripa LW. The changing dental care patterns of participants in a school-based fluoride mouthrinsing program. Pediatr Dent. 1983 Mar;5(1):53-6.

Prevalence study.

Donaldson KV. Rubber cup prophylaxis vs toothbrush cleaning. LDA J. 1983 Winter;41(4):9-11. Review.

Ramos-Gomez F, White GE. The effects of some remineralizing solutions on early occlusal lesions. J Pedod. 1983 Spring;7(3):241-50.

Short-term cross over.

DePaola PF, Soparkar M, Van Leeuwen M, DeVelis R. The anticaries effect of single and combined topical fluoride systems in school children. Arch Oral Biol. 1980;25(10):649-53.

No baseline data.

Spears ND, Goldstein C, Gordinier N, Crysler C. Effects of a thrice yearly application of fluoride gel. Dent Hyg (Chic). 1978 Dec;52(12):569-72.

No baseline data for both groups.

Malloy CM, Shannon IL. A single solution mixture of fluorides for treatment of cavity preparations. Gen Dent. 1982 May-Jun;30(3):225-7.

In vitro.

Weisz WS. A two year study of the efficacy of a sodium fluoride mouth wash. Penn Dent J (Phila). 1947 Nov;5(2):36-43.

Not a controlled study.

Shannon IL. Fluoride treatment programs for high-caries-risk patients. Clin Prev Dent. 1982 Mar-Apr;4(2):11-20.

Review.

Seppä L. Fluoride varnishes in caries prevention. Proc Finn Dent Soc. 1982;78 Suppl 8:1-50. Published elsewhere.

Seppä L, Hausen H, Luoma H. Relationship between caries and fluoride uptake by enamel from two fluoride varnishes in a community with fluoridated water. Caries Res. 1982;16(5):404-12.

Split-mouth.

Easley M. Rinsing with fluoride. A new, school-based program in Ohio. Ohio Dent J. 1981 Mar;55(3):36-41.

Review.

Poulsen S, Gadegaard E, Mortensen B. Cariostatic effect of daily use of a fluoride-containing lozenge compared to fortnightly rinses with 0.2% sodium fluoride. Caries Res. 1981;15(3):236-42.

F supplement study vs. rinse. No other group.

Wade JR. Professional strength fluoride mouthrinses for use in dental offices. J Public Health Dent. 1981 Winter;41(1):5-7.

Letter.

Bissell GD, O'Shea RM, Mann J. Recruitment and participation in a school mouthrinse program. J Public Health Dent. 1980 Winter;40(1):57-63.

Caries not outcome.

Shannon IL. Responses of enamel, dentin, and root surfaces to mouthrinse concentrations of sodium fluoride and stannous fluoride. ASDC J Dent Child. 1980 Jan-Feb;47(1):17-20.

Caries not outcome.


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Goyal%20A%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Billings%20RJ%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gauba%20K%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Chandigarh%20PG%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Perry%20D%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Newman%20MG%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Rossy%20R%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Billings%20RJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Brown%20LR%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kaster%20AG%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Clark%20DC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hanley%20JA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Stamm%20JW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Weinstein%20PL%22%5BAuthor%5D










http://www.ncbi.nlm.nih.gov/pubmed?term=%22Silverstone%20LM%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Vassilopoulou%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22White%20GE%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Holland%20T%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22O'Leary%20K%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22O'Mullane%20D%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22McCall%20DR%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Watkins%20TR%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Stephen%20KW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Collins%20WJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Smalls%20MJ%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Inaba%20D%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kawasaki%20K%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Iijima%20Y%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Taguchi%20N%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hayashida%20H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Yoshikawa%20T%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Furugen%20R%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Fukumoto%20E%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nishiyama%20T%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Tanaka%20K%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Takagi%20O%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Boyd%20CH%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Boyd%20CM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gallien%20GS%20Jr%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Osterbrock%20NL%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Alacam%20T%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Yilmaz%20T%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Sposato%20AL%22%5BAuthor%5D





http://www.ncbi.nlm.nih.gov/pubmed?term=%22Donaldson%20KV%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ramos-Gomez%20F%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22White%20GE%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Soparkar%20M%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Van%20Leeuwen%20M%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22DeVelis%20R%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Spears%20ND%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Goldstein%20C%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gordinier%20N%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Crysler%20C%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Malloy%20CM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Shannon%20IL%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22WEISZ%20WS%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Sepp%C3%A4%20L%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hausen%20H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Luoma%20H%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Easley%20M%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Poulsen%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gadegaard%20E%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Wade%20JR%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bissell%20GD%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22O'Shea%20RM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mann%20J%22%5BAuthor%5D





72

Pogozelski M, Rule JT, Macko DJ, Bailit HL. A neutral sodium fluoride mouthrinse program in two Connecticut communities. J Conn State Dent Assoc. 1980 Winter;54(1):13-4.

Program description.

Smith RS. Making the best use of topical fluoride applications. Dent Stud. 1979 May;57(8):86-90. Review.

Magness WS, Shannon IL, West DC. Office-applied fluoride treatments for orthodontic patients. J Dent Res. 1979 Apr;58(4):1427.

Abstract.

Shannon IL, Edmonds EJ. Topical applications of stannous fluoride: choice of concentration and duration of treatment. J Dent. 1979 Mar;7(1):9-14.

In vitro.

Kolehmainen L, Kerosuo E. The clinical effect of application of a urethane lacquer containing silane fluorine. A one-year study. Proc Finn Dent Soc. 1979;75(4):69-71.

Split mouth.

Heifetz SB, Franchi GJ, Mosley GW, MacDougall O, Brunelle J. Combined anticariogenic effect of fluoride gel-trays and fluoride mouthrinsing in an optimally fluoridated community. Clin Prev Dent. 1979 Jan-Feb;1(1):21-3, 28.

Combinations.

Cooley RL, Barkmeier WW. Reducing recurrent caries with topical stannous fluoride treatment of cavity preparations. Gen Dent. 1979 Jan-Feb;27(1):30-3.

Procedure description.

Tinanoff N, Wei SH, Parkins FM. Effect of a pumice prophylaxis on fluoride uptake in tooth enamel. J Am Dent Assoc. 1974 Feb;88(2):384-9.

Caries not outcome.

Messer HH. The anti-caries actions of topical fluorides. Northwest Dent. 1978 Nov-Dec;57(6):354-7. Report.

Maiwald HJ, Künzel W, Weatherell J. The use of a fluoride varnish in caries prevention. J Int Assoc Dent Child. 1978 Dec;9(2):31-5.

Very poor reporting. No idea what the control group was, although data for a “control” group is presented.

DePaola PF. Combined use of a sodium fluoride prophylaxis paste and a spray containing acidulated sodium fluoride solution. J Am Dent Assoc. 1967 Dec;75(6):1407-11.

Combinations.

Melsen B, Agerboek N, Rölla G. Topical application of 3% monofluorophosphate in a group of schoolchildren. Caries Res. 1979;13(6):344-9.

MFP.

Ripa LW, Leske GS, Forte F, Varma A. Effect of a 0.05% neutral NaF mouthrinse on coronal and root caries of adults. Gerodontology. 1987 Winter;6(4):131-6.

0.05% OTC mouthrinse.

Saunders WA, Wagner MJ. The metabolism of sodium fluoride in a vitamin preparation. J Dent Child. 1966 Mar;33(2):119-22.

Caries is not an outcome.

Beck DJ. Clinical trials of topical fluorides. N Z Dent J. 1974 Oct;70(322):275-81. Review.

Stratemann MW, Shannon IL. Control of decalcification in orthodontic patients by daily self-administered application of a water-free 0.4 per cent stannous fluoride gel. Am J Orthod. 1974 Sep;66(3):273-9.

OTC.

Westwater K. A study of the caries prevalence in first permanent molars of rural Zambian schoolchildren. J Dent. 1974 Sep;2(5):185-9.

Not a trial.

Hirschfield RE, Johnston LE. Decalcification under orthodontic bands. Angle Orthod. 1974 Jul;44(3):218-21.

Split mouth.

Andres CJ, Shaeffer JC, Windeler AS Jr. Comparison of antibacterial properties of stannous fluoride and sodium fluoride mouthwashes. J Dent Res. 1974 Mar-Apr;53(2):457-60.

No caries.

Fayle S, Roberts-Harry D. Fluoride mouthrinse. Br Dent J. 1996 Feb 24;180(4):129. Review.

Axelsson P, Lindhe J. The effect of a preventive programme on dental plaque, gingivitis and caries in schoolchildren. Results after one and two years. J Clin Periodontol. 1974;1(2):126-38.

No fluoride agents.

Mellberg JR, Nicholson CR. Fluoride uptake in vivo deciduous enamel of children from neutral Fluoride and APF mouthrinses. Caries Res. 1974;8(2):148-54.

Fluoride uptake.

Mellberg JR, Nicholson CR. Weekly mouth-rinsing with 3000 ppm of fluoride; the effect of concentration of fluoride in the enamel. J Public Health Dent. 1974 Winter;34(1):2-7.

Fluoride uptake.

Heifetz SB, Horowitz HS, Driscoll WS. Two-year evaluation of a self-administered procedure for the topical application of acidulated phosphate-fluoride; final report. J Public Health Dent. 1970 Winter;30(1):7-12.

Self-administered TF.

Gaum E, Cataldo E, Shiere F. Reaction of the gingiva to acidulated fluoride gel. ASDC J Dent Child. 1973 Nov-Dec;40(6):446-50.

No caries outcome.

Davies GN. Fluoride in the prevention of dental caries. A tentative cost-benefit analysis. 5. The cost-effectiveness of professionally-administered topical applications of fluoride solutions. Br Dent J. 1973 Sep 18;135(6):293-7.

Fluoride tablets.

Davies GN. Fluoride in the prevention of dental caries. A tentative cost-benefit analysis. Br Dent J. 1973 Sep 4;135(5):233-5.

Review.

Alexander WE, McDonald RE, Stookey GK. Effect of stannous fluoride on recurrent caries--results after 24 months. J Dent Res. 1973 Sep-Oct;52(5):1147.

Abstract.

Curson I. The effect on caries increments in dental students of topically applied acidulated phosphate fluoride (APF). J Dent. 1973 Jun;1(5):216-8.

Split mouth.

[No authors listed.] Professionally applied fluorides. Br Dent J. 1973 May 15;134(10):411-2. Review.

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Pogozelski%20M%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Rule%20JT%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Macko%20DJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bailit%20HL%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Smith%20RS%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Magness%20WS%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22West%20DC%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Edmonds%20EJ%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kolehmainen%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kerosuo%20E%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Franchi%20GJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mosley%20GW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22MacDougall%20O%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Brunelle%20J%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Cooley%20RL%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Barkmeier%20WW%22%5BAuthor%5D





http://www.ncbi.nlm.nih.gov/pubmed?term=%22Parkins%20FM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Messer%20HH%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Maiwald%20HJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22K%C3%BCnzel%20W%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Weatherell%20J%22%5BAuthor%5D








http://www.ncbi.nlm.nih.gov/pubmed?term=%22Forte%20F%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Varma%20A%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Saunders%20WA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Wagner%20MJ%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Beck%20DJ%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Stratemann%20MW%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Westwater%20K%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hirschfield%20RE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Johnston%20LE%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Andres%20CJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Shaeffer%20JC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Windeler%20AS%20Jr%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Fayle%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Roberts-Harry%20D%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lindhe%20J%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nicholson%20CR%22%5BAuthor%5D









http://www.ncbi.nlm.nih.gov/pubmed?term=%22Driscoll%20WS%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gaum%20E%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Cataldo%20E%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Shiere%20F%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Davies%20GN%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Davies%20GN%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Alexander%20WE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22McDonald%20RE%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Curson%20I%22%5BAuthor%5D




73

Ripa LW. Recommendations for the use of topical fluoride self-application techniques in a preventive office program. NY State Dent J. 1973 Apr;39(4):227-33.

Review.

Birkeland JM. Intra- and interindividual observations on fluoride ion activity and retained fluoride with sodium fluoride mouth rinses. Caries Res. 1973;7(1):39-55.

No caries outcome.

Englander HR. A perspective on prophylaxis of dental caries by topical fluoride. Dent Clin North Am. 1972 Oct;16(4):673-80.

Review.

Parkins FM. Retention of fluoride with chewable tablets and a mouthrinse. J Dent Res. 1972 Sep-Oct;51(5):1346-9.

Fluoride retention.

Miller JT, Shannon IL. A clinical report. Water-free stannous-fluoride gel and post-irradiation caries. J Public Health Dent. 1972 Spring;32(2):127.

Note.

DePaola PF, Aasenden R, Brudevold F. The use of topically applied acidulated phosphate-fluoride preceded by mild etching of the enamel: a one-year clinical trial. Arch Oral Biol. 1971 Oct;16(10):1155-63.

No relevant control group.

Zachrisson BU, Zachrisson S. Caries incidence and oral hygiene during orthodontic treatment. Scand J Dent Res. 1971;79(6):394-401.

No F agent.

Horowitz HS, Chamberlin SR. Pigmentation of teeth following topical applications of stannous fluoride in a nonfluoridated area. J Public Health Dent. 1971 Winter;31(1):32-7.

No caries outcome.

Scola FP. Self-preparation stannous fluoride prophylactic technique in preventive dentistry: report after two years. J Am Dent Assoc. 1970 Dec;81(6):1369-72.

No relevant control group.

Yardeni J, Hermel J. The anticariogenic effect of sodium fluoride. J Dent Res. 1969 Sep-Oct;48(5):965.

Abstract.

Swerdloff G, Shannon IL. Feasibility of the use of stannous fluoride mouthwash in a school system. ASDC J Dent Child. 1969 Sep-Oct;36(5):363-8.

Abstract.

Mellberg JR, Nicholson CR, Miller BG, Englander HR. Acquisition of fluoride in vivo by enamel from repeated topical sodium fluoride applications in a fluoridated area: a preliminary report. J Dent Res. 1968 Sep-Oct;47(5):733-6.

No caries outcome.

PePaola PF, Wellock WD, Maitland A, Brudevold F. The relationship of cariostasis, oral hygiene, and past caries experience in children receiving three sprays annually with acidulated phosphate-fluoride: three-year results. J Am Dent Assoc. 1968 Jul;77(1):91-4.

Intervention not consistent across years.

Murray JJ, Majid ZA. The prevalence and progression of approximal caries in the deciduous dentition in British children. Br Dent J. 1978 Sep 19;145(6):161-4. DePaola PF. Caries in our aging population: what are we learning? Cariology for the Nineties. (1993) University of Rochester Press, pp. 25-35.

Not controlled.

Lagutina NJ, Vorobjev VS, Grabetskij AA, Stepanov AV. Clinical evaluation of home fluoride-containing varnish. Quintessence Int Dent Dig. 1978 Feb;9(2):63-6.

Investigative varnish.

Fischman SL, English JA, Albino JE, Bissell GD, Greenberg JS, Juliano DB, O'Shea RM, Slakter MJ. A comprehensive caries control program--design and evaluation of the clinical trial. J Dent Res. 1977 Oct;56 Spec No:C99-103.

Combinations.

Shannon IL. A self-treatment program of chemical preventative dentistry for high-risk patients. Ariz Dent J. 1977;23(1):19, 26-9.

Not controlled.

Levine RS. An initial clinical assessment of a mineralising mouthrinse. Br Dent J. 1975 Apr 1;138(7):249-53.

Not on fluoride.

Geiger AM, Gorelick L, Gwinnett AJ, Griswold PG. The effect of a fluoride program on white spot formation during orthodontic treatment. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):29-37.

Combinations.

Seppä L, Hausen H, Tuutti H, Luoma H. Effect of a sodium fluoride varnish on the progress of initial caries lesions. Scand J Dent Res. 1983:91 (2).

Split mouth.

Hutton J, Koulourides T, Borden L. Evaluation of cariostatic disciplines for postradiation caries. Caries Res. 1982;16(5):390-7.

Case reports.

Aasenden R, DePaola PF, Brudevold F. Effects of daily rinsing and ingestion of fluoride solutions upon dental caries and enamel fluoride. Arch Oral Biol. 1972 Dec;17(12):1705-14.

Solution was swallowed.

Hirschfield RE. Control of decalcification by use of fluoride mouthrinse. ASDC J Dent Child. 1978 Nov-Dec;45(6):458-60.

Phosflur rinse OTC.

Frankl SN, Fleisch S, Diodati RR. The topical anticariogenic effect of daily rinsing with an acidulated phosphate fluoride solution. J Am Dent Assoc. 1972 Oct;85(4):882-6.

Phosflur OTC.

Rugg-Gunn AJ, Holloway PJ, Davies TG. Caries prevention by daily fluoride mouthrinsing. Report of a three-year clinical trial. Br Dent J. 1973 Oct 16;135(8):353-60.

0.05% NaF rinse.

Forsman B. The caries preventing effect of mouthrinsing with 0.025 percent sodium fluoride solution in Swedish children. Community Dent Oral Epidemiol. 1974;2(2):58-65.

0.2% vs. 0.025% - No relevant control group.

Ashley FP, Mainwaring PJ, Emslie RD, Naylor MN. Clinical testing of a mouthrinse and a dentifrice containing fluoride. A two-year supervised study in school children. Br Dent J. 1977 Nov 15;143(10):333-8.

100 ppm = 0.01% F ion OTC.

Finn SB, Moller P, Jamison H, Regattieri L, Manson-Hing L. The clinical cariostatic effectiveness of two concentrations of acidulated phosphate-fluoride mouthwash. J Am Dent Assoc. 1975 Feb;90(2):398-402.

100 and 200 ppm F ion concentration OTC.







http://www.ncbi.nlm.nih.gov/pubmed?term=%22Englander%20HR%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Parkins%20FM%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Miller%20JT%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Aasenden%20R%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Zachrisson%20BU%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Zachrisson%20S%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Chamberlin%20SR%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Yardeni%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hermel%20J%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Swerdloff%20G%22%5BAuthor%5D





http://www.ncbi.nlm.nih.gov/pubmed?term=%22Miller%20BG%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22PePaola%20PF%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Wellock%20WD%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Maitland%20A%22%5BAuthor%5D





http://www.ncbi.nlm.nih.gov/pubmed?term=%22Murray%20JJ%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lagutina%20NJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Vorobjev%20VS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Grabetskij%20AA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Stepanov%20AV%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22English%20JA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Albino%20JE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bissell%20GD%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Greenberg%20JS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Juliano%20DB%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22O'Shea%20RM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Slakter%20MJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Slakter%20MJ%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Levine%20RS%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Geiger%20AM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gorelick%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gwinnett%20AJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Griswold%20PG%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Aasenden%20R%22%5BAuthor%5D





http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hirschfield%20RE%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Frankl%20SN%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Fleisch%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Diodati%20RR%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Rugg-Gunn%20AJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Holloway%20PJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Davies%20TG%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Forsman%20B%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ashley%20FP%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mainwaring%20PJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Emslie%20RD%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Naylor%20MN%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Finn%20SB%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Moller%20P%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Jamison%20H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Regattieri%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Manson-Hing%20L%22%5BAuthor%5D



74

Muhler JC, Stookey GK, Bixler D. Evaluation of the anticariogenic effect of mixtures of stannous fluoride and soluble phosphates. ASDC J Dent Child. 1965 32(3).

Review.

Foster RD. Self-application of topically applied stannous fluoride: a feasibility study. J Am Dent Assoc. 1965 70(2).

Caries not outcome.

Alexander WE, McDonald RE, Stookey GK. Effectiveness of a stable 30 percent stannous fluoride solution in the prevention of recurrent dental caries. Journal of the Indiana Dental Association. 1969 48(4).

Applied to cavity walls.

Marthaler TM. Caries-inhibition after seven years of unsupervised use of an amine fluoride dentifrice. Br Dent J. 1968 124(11).

Amine fluoride.

Corbett JA, Shannon IL. Prevention of decalcification in orthodontic patients: a preliminary clinical trial with a mixture of fluorides. J Colo Dent Assoc. 1980 Mar;58(4):16-7.

Combinations.

Sköld L, Sundquist B, Eriksson B, Edeland C. Four-year study of caries inhibition of intensive Duraphat application in 11-15-year-old children. Community Dent Oral Epidemiol. 1994 Feb;22(1):8-12.

Children in test group used F prophy paste + Duraphat and control used only Duraphat.

McCormick J, Manson-Hing L, Wolff AE, Koulourides T. Remineralizing mouthwash rationale and a pilot clinical study. Ala J Med Sci. 1970 Jan;7(1):92-7.

No relevant agent.

Gray AS, Gunther DM, Munns PM. Fluoride paste and rinse in a school dental program. J Can Dent Assoc. 1980 46(10).

Combination.

Luoma H, Murtomaa H, Nuuja T, Nyman A, Nummikoski P, Ainamo J, Luoma AR. A simultaneous reduction of caries and gingivitis in a group of schoolchildren receiving chlorhexidine-fluoride applications. Results after 2 years. Caries Res. 1978;12(5):290-8.

Unusual concentration.

Hall GL. Stannous fluoride (0.1 percent) mouthwash study. SAM-TR-68-78. Tech Rep SAM-TR. 1968 Aug:1-2.

OTC concentration.

Swerdloff G, Shannon IL. A feasibility study of the use of a stannous fluoride mouthwash in a school preventive dentistry program. SAM-TR-67-52. Tech Rep SAM-TR. 1967 Jun:1-10.

0.1% SnF rinse – OTC concentration.

Brandt RS, Slack GL, Waller DF. The use of a sodium fluoride mouthwash in reducing the dental caries increment in eleven year old English school children. Proceedings of the British Paedodontic Society. 1972 (2).

Started with a group of kids. Found that baseline caries became different due to losses and so they decided to report only for matched pairs.

Murray JJ, Winter GB, Hurst CP. Duraphat fluoride varnish. A 2-year clinical trial in 5-year-old children. Br Dent J. 1977 Jul 5;143(1):11-7.

Split mouth.

Lindquist B, Edward S, Torell P, Krasse B. Effect of different carriers preventive measures in children highly infected with mutans streptococci. Scand J Dent Res. 1989 Aug;97(4):330-7.

The control group was treated based on dentists’ judgment and on an average received 4 topical fluoride applications over the 2 year study period.

Spak CJ, Johnson G, Ekstrand J. Caries incidence, salivary flow rate and efficacy of fluoride gel treatment in irradiated patients. Caries Res. 1994;28(5):388-93.

0.42% F vs. 1.23% APF for 4 weeks.

Twetman S, Petersson LG. Prediction of caries in pre-school children in relation to fluoride exposure. Eur J Oral Sci. 1996 Oct-Dec;104(5-6):523-8.

Testing a chairside strep test. Caries data part of the original paper is the one below.

Green E. A clinical evaluation of two methods of caries prevention in newly-erupted first permanent molars. Aust Dent J. 1989 Oct;34(5):407-9.

Silver fluoride excluded

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Corbett%20JA%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Sk%C3%B6ld%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Sundquist%20B%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Eriksson%20B%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Edeland%20C%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22McCormick%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Manson-Hing%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Wolff%20AE%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Koulourides%20T%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Murtomaa%20H%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nuuja%20T%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nyman%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nummikoski%20P%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ainamo%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Luoma%20AR%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hall%20GL%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Swerdloff%20G%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Murray%20JJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Winter%20GB%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hurst%20CP%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lindquist%20B%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Edward%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Torell%20P%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Krasse%20B%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Spak%20CJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Johnson%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ekstrand%20J%22%5BAuthor%5D







http://www.ncbi.nlm.nih.gov/pubmed?term=%22Green%20E%22%5BAuthor%5D



75

Keltjens HM, Schaeken MJ, van der Hoeven JS, Hendriks JC. Caries control in overdenture patients: 18-month evaluation on fluoride and chlorhexidine therapies. Caries Res. 1990;24(5):371-5.

Control group received semiannual 0.4% NaF and test received daily 0.1% NaF. OTC.

Disney JA, Graves RC, Stamm JW, Bohannan HM, Abernathy JR. Comparative effects of a 4-year fluoride mouthrinse program on high and low caries forming grade 1 children. Community Dent Oral Epidemiol. 1989 Jun;17(3):139-43.

Many combinations. NPDDP paper.

Leverett DH, McHugh WD, Jensen OE. Dental caries and staining after twenty-eight months of rinsing with stannous fluoride or sodium fluoride. J Dent Res. 1986 Mar;65(3):424-7.

0.05% NaF.

Obersztyn A, Kolwinski K, Trykowski J, Starosciak S. Effects of stannous fluoride and amine fluorides on caries incidence and enamel solubility in adults. Aust Dent J. 1979 Dec;24(6):395-7.

SnF prophy paste and solution in the test group and no treatment control.

Seppä L, Tuutti H, Luoma H. Three-year report on caries prevention of using fluoride varnishes for caries risk children in a community with fluoridated water. Scand J Dent Res. 1982 Apr;90(2):89-94.

Split mouth.

Ringelberg ML, Webster DB, Dixon DO, LeZotte DC. The caries-preventive effect of amine fluorides and inorganic fluorides in a mouthrinse or dentifrice after 30 months of use. J Am Dent Assoc. 1979 Feb;98(2):202-8.

Amine fluoride.

McConchie JM, Richardson AS, Hole LW, McCombie F, Kolthammer J. Caries-preventive effect of two concentrations of stannous fluoride mouthrinse. Community Dent Oral Epidemiol. 1977 Nov;5(6):278-83.

0.01 and 0.02% SnF OTC.

Boyd RL. Comparison of three self-applied topical fluoride preparations for control of decalcification. Angle Orthod. 1993 Spring;63(1):25-30.

All OTC concentrations.

McDonald SP, Sheiham A. A clinical comparison of non-traumatic methods of treating dental caries. Int Dent J. 1994 Oct;44(5):465-70.

Split mouth.

Bánóczy J, Nemes J. Effect of amine fluoride (AmF)/stannous fluoride (SnF2) toothpaste and mouthwashes on dental plaque accumulation, gingivitis and root-surface caries. Proc Finn Dent Soc. 1991;87(4):555-9.

No control for the NaF group.

Alexander SA, Ripa LW. Effects of self-applied topical fluoride preparations in orthodontic patients. Angle Orthod. 2000 Dec;70(6):424-30.

No control groups for the prevident treatment; special population; head-to-head trial

Torell P, Gerdin PO. Fortnightly fluoride rinsing combined with topical painting of fluoride solutions containing Al-, Fe-, and Mn-ions. Scand J Dent Res. 1977 Jan;85(1):38-40.

No concurrent control group.

Bawden JW, Granath L, Holst K, Koch G, Krasse P, Rootzén H. Effect of mouthrinsing with a sodium fluoride solution in children with different caries experience. Swed Dent J. 1980;4(3):111-7.

Primary data is in Koch 1967.

Seppä L. Fluoride content of enamel during treatment and 2 years after discontinuation of treatment with fluoride varnishes. Caries Res. 1984;18(3):278-81.

Caries not an outcome.

ten Cate JM, Shariati M, Featherstone JD. Enhancement of (salivary) remineralization by 'dipping' solutions. Caries Res. 1985;19(4):335-41.

In vitro study.

Ogaard B, Arends J, Rølla G. Action of fluoride on initiation of early root surface caries in vivo. Caries Res. 1990;24(2):142-4.

In vitro study.

Dénes J, Gábris K. Results of a 3-year oral hygiene programme, including amine fluoride products, in patients treated with fixed orthodontic appliances. Eur J Orthod. 1991 Apr;13(2):129-33.

Amine fluorides.

Wei SH, Kaqueller JC, Massler M. Remineralization of carious dentin. J Dent Res. 1968 May-Jun;47(3):381-91.

In vitro study.

J Orofac Orthop. 1997;58(4):206-13. Fluoride in combination of Cervitec.

Brånemark PI. Local tissue effects of sodium fluoride. Odontol Revy. 1967;18(3):273-94. No reason given.

Haugejorden O, Nord A. Caries incidence after topical application of varnishes containing different concentrations of sodium fluoride: 3-year results. Scand J Dent Res. 1991 Aug;99(4):295-300.

Duraphat tested against test varnish. No other control group.

Birkeland JM, Torell P. Caries-preventive fluoride mouthrinses. Caries Res. 1978;12 Suppl 1:38-51. Review paper.

Vrbic V, Kosmelj B+KOSMELJ B, Ravnik C. A 3-year study among Yugoslavian schoolchildren on caries reduction after topical application of 4% NaF-PO4. Community Dent Oral Epidemiol. 1974;2(4):163-5.

Non-standard fluoride concentration.

Radike AW, Gish CW, Peterson JK, King JD, Segreto VA. Clinical evaluation of stannous fluoride as an anticaries mouthrinse. J Am Dent Assoc. 1973 Feb;86(2):404-8.

0.1% SnF OTC.

Moreira BH, Guimaraes LO, Viera S, Piedade EF. [Fluoride mouthwashes in combination with fluoridation of the public water supply for the prevention of dental caries.] Revista Da Associacao Paulista de Cirurgioes Dentistas. 1981 35(4).

Non-English.

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Keltjens%20HM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Schaeken%20MJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22van%20der%20Hoeven%20JS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hendriks%20JC%22%5BAuthor%5D







http://www.ncbi.nlm.nih.gov/pubmed?term=%22Abernathy%20JR%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Leverett%20DH%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22McHugh%20WD%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Jensen%20OE%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Obersztyn%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kolwinski%20K%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Trykowski%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Starosciak%20S%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Tuutti%20H%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ringelberg%20ML%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Webster%20DB%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Dixon%20DO%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22LeZotte%20DC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22McConchie%20JM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Richardson%20AS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hole%20LW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22McCombie%20F%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kolthammer%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Boyd%20RL%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22McDonald%20SP%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Sheiham%20A%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22B%C3%A1n%C3%B3czy%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nemes%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Alexander%20SA%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gerdin%20PO%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bawden%20JW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Granath%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Holst%20K%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Krasse%20P%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Rootz%C3%A9n%20H%22%5BAuthor%5D






http://www.ncbi.nlm.nih.gov/pubmed?term=%22ten%20Cate%20JM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Shariati%20M%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Featherstone%20JD%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ogaard%20B%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Arends%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22R%C3%B8lla%20G%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22D%C3%A9nes%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22G%C3%A1bris%20K%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kaqueller%20JC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Massler%20M%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Br%C3%A5nemark%20PI%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Haugejorden%20O%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nord%20A%22%5BAuthor%5D






http://www.ncbi.nlm.nih.gov/pubmed?term=%22Vrbic%20V%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kosmelj%20B%2BKOSMELJ%20B%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ravnik%20C%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Radike%20AW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gish%20CW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Peterson%20JK%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22King%20JD%22%5BAuthor%5D



76

Molina XM, Rodriguez GP, Sepulveda MM, Urbina TR, Vargas SJ. [Increase of caries in a school children group that participated in a weekly mouth wash program with sodium fluoride 0.2.] Revista de la Facultad de Odontología de la Universidad de Chile. 1987: 5(2).

Non-English.

Mestrinho HD, et al. [Prevention of dental caries through topical application of APF gel with plastic trays.] Odontologo Moderno. 1983 (10).

Non-English.

Moreira BH,Tumang AJ. [Mouthwashes with 1 per cent sodium fluoride solutions in the prevention of dental caries.] Revista Brasileira de Odontologia. 1971 28(167).

Non-English.

Moreira BH,Tumang AJ. [Prevention of dental caries by means of mouthwashes with 0.1 solutions of sodium fluoride: results of a 2 year study.] Revista Brasileira de Odontologia. 1972 29(173).

Non-English.

Horowitz HS. Caries prevention and various fluoride preparations. Refuat Hapeh Vehashinayim. 1974 Oct;23:91-6.

Non-English.

Kukleva MP, Kondeva VK. Dynamics of caries activity and caries reduction in group prophylaxis with fluoride gel. Folia Med (Plovdiv). 2001;43(1-2):12-5.

Product not commercially available in U.S.

Marthaler TM. Improved oral health of schoolchildren of 16 communities after 8 years of prevention. I. Combining DMF data from the communities. Helv Odontol Acta. 1974 Oct;18(2):119-42.

Prevalence study.

Marthaler TM, König KG, Mühlemann HR. The effect of a fluoride gel used for supervised toothbrushing 15 or 30 times per year. Helv Odontol Acta. 1970 Oct;14(2):67-77.

Amine Fluoride.

Marthaler TM. Caries-inhibiting effect of fluoride tablets. Helv Odontol Acta. 1969 Apr;13(1):1-13. Supplement study.

Koch G. Caries increment in schoolchildren during and two years after end of supervised rinsing of the mouth with sodium fluoride solution. Odontol Revy. 1969;20(3):323-30.

Post-treatment.

Hollender L, Koch G. Effect of local application of fluoride on initial demineralization of buccal surface of maxillary incisors. Clinical assessment from colour slides. Sven Tandlak Tidskr. 1976: 69 (1).

0.5% NaF rinse and photographs used to evaluate caries.

Arcieri RM, de Lourdes Carvalho M, Goncalves LM, Alfonso de Almeida H, Pereira AL, de Oliveira EM. [Incidence of dental caries in students after topical application of acidulated phosphate fluoride with or without fluoride mouthwashes: comparative study.] Revista do Centro de Ciencias Biomedicas Da Universidade Federal de Uberlandia. 1985: 1(1).

Non-English.

Buhe H, Buttner W, Barlage B. [3-year clinical tooth cream test with toothpastes of varying fluoride content: 0.8% and 1.2% sodium monofluorophosphate.] Quintessenza. 1984: 35(1).

Non-English.

Effectiveness of fluoride gel. J Am Dent Assoc. 1989;119(1):10, 12, 172-174. Letter.

Researchers investigate methods to prevent caries on roots and crowns. J Am Dent Assoc. 1992;123(11):22, 24.

Announcement.

Abelson DC, Levin MP. Multiple use of fluoride for adult patients. N Y J Dent. 1977;47(5):146-148.

Not a clinical study.

Adler P. Fluorides and dental health. Monogr Ser World Health Organ. 1970;59:323-354.


Andrus PL. The role of fluoride in the prevention of dental caries. Tex Med. 1982;78(12):57-61.

Review.

Brailsford SR, Fiske J, Gilbert S, Clark D, Beighton D. The effects of the combination of chlorhexidine/thymol- and fluoride-containing varnishes on the severity of root caries lesions in frail institutionalised elderly people. J Dent. 2002;30(7-8):319-324.

CHXF combination.

Brandt RS. Fluoride and dental caries. Practitioner. 1975;214(1281):388-389. Review.

Carberry FJ. Fluoride rinse. An alternative to restoration in Barbuda, West Indies. N Y State Dent J. 1999;65(2):34-38.


Craig GG, Powell KR. Dental caries in susceptible fissures after prolonged fluoride application. Community Dent Oral Epidemiol. 1979;7(3):158-160.

Slow release.

Craig GG, Powell KR, Cooper MH. Caries progression in primary molars: 24-month results from a minimal treatment programme. Community Dent Oral Epidemiol. 1981;9(6):260-265.


DePaola PF, Wellock WD, Maitland A, Brudevold F. The relationship of cariostasis, oral hygiene, and past caries experience in children receiving three sprays annually with acidulated phosphate-fluoride: three-year results. J Am Dent Assoc. 1968.

Sprays.

Dismer GA. Sodium fluoride mouthrinse. Three-year study. Ill Dent J. 1982;51(3):158-160.


Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990;50(1):13-17. Driscoll WS, Nowjack-Raymer R, Selwitz RH, Li SH, Heifetz SB. A comparison of the caries-preventive effects of fluoride mouthrinsing, fluoride tablets, and both procedures combined: final results after eight years. J Public Health Dent. 1992;52(2):111-116.

No control group.



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kukleva%20MP%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kondeva%20VK%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Marthaler%20TM%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22K%C3%B6nig%20KG%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22M%C3%BChlemann%20HR%22%5BAuthor%5D








77

Eckhaus B, Silverstein S, Fine J, Boriskin J. The community caries prevention demonstration program: fluoride mouthrinses for grades K-12. CDA J. 1982;10(1):43-47.


Goggin G, O'Mullane DM, Welton H. The effectiveness of a combined fluoride mouthrinse and fissure sealant programme. J Ir Dent Assoc. 1991;37(2):38-40.

Combination.

Grissom DK, Dedenbostel RE, Cassel WJ, Murray RT. A comparative study of systemic sodium fluoride and topical stannous fluoride applications in preventive dentistry. ASDC J Dent Child. 1964. p. 314-322.

Supplements versus topical.

Harris R. Observations on the effect of eight per cent stannous fluoride on dental caries in children. Australian Dental Journal. 1963 Aug;8(4):335-340.

Solution.

Holve S. An observational study of the association of fluoride varnish applied during well child visits and the prevention of early childhood caries in American Indian children. Matern Child Health J. 2008;12 Suppl 1:64-67.

Not a clinical study for differences.

Horowitz HS, Heifetz SB, Meyers RJ, Driscoll WS, Korts DC. Evaluation of a combination of self-administered fluoride procedures for the control of dental caries in a nonfluoride area: findings after four years. J Am Dent Assoc. 1979 Feb;98(2):219-23.

Retrospective study.

Howell CL, Gish CW, Smiley RD, Muhler JC. Effect of topically applied stannous fluoride on dental caries experience in children. J Am Dent Assoc. 1955 Jan;50(1):14-7.

Solution.

Lesher D. Mouthrinsing project. Bull Mich Dent Hyg Assoc. 1976;6(1):13.

Announcement.

Marks RG, Conti AJ, Moorhead JE, Cancro L, D'Agostino RB. Results from a three-year caries clinical trial comparing NaF and SMFP fluoride formulations. International Dental Journal. 1994. p. 275-285.

SMFP.

Marks RG, D'Agostino R, Moorhead JE, Conti AJ, Cancro L. A fluoride dose-response evaluation in an anticaries clinical trial. J Dent Res. 1992;71(6):1286-1291.

SMFP.

Marthaler TM. Reduction of caries, gingivitis and calculus after eight years of preventive measures--observations in seven communities. Helv Odontol Acta. 1972 Oct;16(2):69-83.

Observational.

Marthaler TM. Decrease of DMF-levels 4 years after the introduction of a caries-preventive program, observations in 5819 schoolchildren of 20 communities. Helv Odontol Acta. 1972 Oct;16(2):45-68.

Observational.

Nemes J, Bánóczy J, Wierzbicka M, Rost M. Clinical study on the effect of amine fluoride/stannous fluoride on exposed root surfaces. The Journal of Clinical Dentistry. 1992. p. 51-53.

No control for fluoride.

Øgaard B, Alm AA, Larsson E, Adolfsson U. A prospective, randomized clinical study on the effects of an amine fluoride/stannous fluoride toothpaste/mouthrinse on plaque, gingivitis and initial caries lesion development in orthodontic patients. European Journal of Orthodontics. 2006. p. 8-12.

Toothpaste study.

Øgaard B, Larsson E, Henriksson T, Birkhed D, Bishara SE. Effects of combined application of antimicrobial and fluoride varnishes in orthodontic patients. Am J Orthod Dentofacial Orthop. 2001;120(1):28-35.

No baseline for the control group.

Petchel KA, Mello AF. School-based weekly sodium fluoride rinse program. Results after three and one-half years. Clin Prev Dent. 1982;4(2):21-23.

Prevalence.

Purdell-Lewis DJ, Arends J, Groeneveld A. The effect of differing concentrations of SnF2 on demineralized enamel. Caries Res. 1978;12(1):43-51.

In vitro.

Ripa LW. Community- and school-based caries preventive programs. Participation of New York State children. N Y State Dent J. 1985;51(7):408-412.

Description.

Ripa LW, Leske GS, Forte F. The combined use of pit and fissure sealants and fluoride mouthrinsing in second and third grade children: one-year clinical results. Pediatr Dent. 1986;8(3):158-162.

Sealants study.

Ripa LW, Leske GS, Forte F. The combined use of pit and fissure sealants and fluoride mouthrinsing in second and third grade children: final clinical results after two years. Pediatr Dent. 1987;9(2):118-120.

Sealants study.

Ripa LW, Leske GS, Sposato A. The surface-specific caries pattern of participants in a school-based fluoride mouthrinsing program with implications for the use of sealants. J Public Health Dent. 1985;45(2):90-94.

Prevalence study.

78

Shapira J, Stabholz A. A comprehensive 30-month preventive dental health program in a pre-adolescent population with Down's syndrome: a longitudinal study. Spec Care Dentist. 1996;16(1):33-37.

Sealant study.

Sharma U, Jain RL, Pathak A. A clinical assessment of the effectiveness of mouthwashes in comparison to toothbrushing in children. J Indian Soc Pedod Prev Dent. 2004;22(2):38-44.

Plaque scores.

Sledd JL. Applying fluoride varnish to pediatric patients to prevent caries. Northwest Dent. 2007 Jan-Feb;86(1):4, 66.

Letter.

Sterritt GR, Frew RA, Rozier RG, Brunelle JA. Evaluation of a school-based fluoride mouthrinsing and clinic-based sealant program on a non-fluoridated island. Community Dent Oral Epidemiol. 1990;18(6):288-293.


Toolson LB, Smith DE. A five-year longitudinal study of patients treated with overdentures. J Prosthet Dent. 1983;49(6):749-756.

Paper reporting on 2 year caries data included.

Leksell E. Evaluation of three caries preventive methods: a 3-year radiological study in Swedish urban school children with high caries risk. (Abstract). International Journal of Paediatric Dentistry /the British Paedodontic Society [and] the International Association of Dentistry for Children. 2003. p. 49.

Not a fluoride study.

Tewari A, Chawla HS, Utreja AK. Dental caries preventive effect of sodium fluoride and acidulated fluoride phosphate. 1 1/2 years clinical trial. J Indian Dent Assoc. 1983;55(4):133-8.

Fluoride “solution” not currently available.

Schirrmeister JF, Gebrande JP, Altenburger MJ, Mönting JS, Hellwig E. Effect of dentifrice containing 5000 ppm fluoride on non-cavitated fissure carious lesions in vivo after 2 weeks. Am J Dent. 2007 Aug;20(4):212-6.

Two week study.

Shannon IL, St Clair JR, Pratt GA, West DC. Stannous fluoride versus sodium fluoride in preventive treatment of orthodontic patients. Australian Orthodontic Journal. 1978;5(1):18–24.

Incorrect outcomes measure (no data); specialized populations (orthodontic patients that are banded).

Seppä L, Pöllänen L, Hausen H. Caries-preventive effect of fluoride varnish with different fluoride concentrations. Caries Res. 1994;28(1):64-7.

1.13% F varnish not available in U.S.

Packer MW, Laswell HR, Doyle J, Naff HH, Brown F. Cariostatic effects of fluoride mouthrinses in a non-fluoridated community. J Tenn Dent Assoc. 1975 Jan;55(1):22-6.

0.1% APF rinse. head-to-head data

Laswell HR, Packer MW, Wiggs JS. Cariostatic effects of fluoride mouthrinses in a fluoridated community. J Ky Dent Assoc. 1975 Oct;27(4):21-5. Laswell HR, Pacher MW, Wiggs JS. Cariostatic effects of fluoride mouthrinses in a fluoridated community. J Tenn Dent Assoc. 1975 Oct;55(4):198.

0.1% APF rinse. head-to-head data

Baysan A, Lynch E, Ellwood R, Davies R, Petersson L, Borsboom P. Reversal of primary root caries using dentifrices containing 5,000 and 1,100 ppm fluoride. Caries Res. 2001 Jan-Feb;35(1):41-6 Lynch E, Baysan A, Ellwood R, Davies R, Petersson L, Borsboom P. Effectiveness of two fluoride dentifrices to arrest root carious lesions. Am J Dent. 2000 Aug;13(4):218-20.

Too short of follow-up (3 and 6 months); arrests and reversals; did not report outcomes as increments

Kirkegaard E, Petersen G, Poulsen S, Holm SA, Heidmann J. Caries-preventive effect of Duraphat varnish applications versus fluoride mouthrinses: 5-year data. Caries Res. 1986;20(6):548-55.

Duraphat vs. rinse; head-to-head

Seppä L, Pöllänen L. Caries preventive effect of two fluoride varnishes and a fluoride mouthrinse. Caries Res. 1987;21(4):375-9.

Duraphat vs. Fluorprotector vs. rinse; head-to-head

Koch G, Petersson LG, Rydén H. Effect of fluoride varnish (Duraphat) treatment every six months compared with weekly mouthrinses with 0.2 per cent NaF solution on dental caries. Swed Dent J. 1979;3(2):39-44.

Head-to-head


http://www.ncbi.nlm.nih.gov/pubmed?term=%22P%C3%B6ll%C3%A4nen%20L%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Packer%20MW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Laswell%20HR%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Doyle%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Naff%20HH%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Brown%20F%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Packer%20MW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Wiggs%20JS%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Pacher%20MW%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Wiggs%20JS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=Baysan%20A%5BAuthor%5D&cauthor=true&cauthor_uid=11125195

http://www.ncbi.nlm.nih.gov/pubmed?term=Lynch%20E%5BAuthor%5D&cauthor=true&cauthor_uid=11125195

http://www.ncbi.nlm.nih.gov/pubmed?term=Ellwood%20R%5BAuthor%5D&cauthor=true&cauthor_uid=11125195

http://www.ncbi.nlm.nih.gov/pubmed?term=Davies%20R%5BAuthor%5D&cauthor=true&cauthor_uid=11125195

http://www.ncbi.nlm.nih.gov/pubmed?term=Petersson%20L%5BAuthor%5D&cauthor=true&cauthor_uid=11125195

http://www.ncbi.nlm.nih.gov/pubmed?term=Borsboom%20P%5BAuthor%5D&cauthor=true&cauthor_uid=11125195



http://www.ncbi.nlm.nih.gov/pubmed?term=Lynch%20E%5BAuthor%5D&cauthor=true&cauthor_uid=11763936

http://www.ncbi.nlm.nih.gov/pubmed?term=Baysan%20A%5BAuthor%5D&cauthor=true&cauthor_uid=11763936

http://www.ncbi.nlm.nih.gov/pubmed?term=Ellwood%20R%5BAuthor%5D&cauthor=true&cauthor_uid=11763936

http://www.ncbi.nlm.nih.gov/pubmed?term=Davies%20R%5BAuthor%5D&cauthor=true&cauthor_uid=11763936

http://www.ncbi.nlm.nih.gov/pubmed?term=Petersson%20L%5BAuthor%5D&cauthor=true&cauthor_uid=11763936

http://www.ncbi.nlm.nih.gov/pubmed?term=Borsboom%20P%5BAuthor%5D&cauthor=true&cauthor_uid=11763936

http://www.ncbi.nlm.nih.gov/pubmed?term=american+journal+of+dentistry%5BJour%5D+AND+2000%5Bpdat%5D+AND+lynch%5Bauthor%5D&cmd=detailssearch

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kirkegaard%20E%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Petersen%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Poulsen%20S%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Holm%20SA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Heidmann%20J%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22P%C3%B6ll%C3%A4nen%20L%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ryd%C3%A9n%20H%22%5BAuthor%5D



79

Seppä L, Leppänen T, Hausen H. Fluoride varnish versus acidulated phosphate fluoride gel: a 3-year clinical trial. Caries Res. 1995;29(5):327-30.

Head-to-head

Bruun C, Bille J, Hansen KT, Kann J, Qvist V, Thylstrup A. Three-year caries increments after fluoride rinses or topical applications with a fluoride varnish. Community Dent Oral Epidemiol. 1985 Dec;13(6):299-303.

Varnish vs. rinse; Head-to-head

Mellberg JR, Franchi GJ, Englander HR, Mosley GW, Nicholson CR. Short intensive topical APF applications and dental caries in a fluoridated area. Community Dent Oral Epidemiol. 1978 May;6(3):117-20.

Application methods not currently used in practice

Flório FM, Pereira AC, Meneghim Mde C, Ramacciato JC. Evaluation of non-invasive treatment applied to occlusal surfaces. ASDC J Dent Child. 2001 Sep-Dec;68(5-6):326-31, 301.

Head-to-head

Shern RJ, Duany LF, Senning RS, Zinner DD. Clinical study of an amine fluoride gel and acidulated phosphate fluoride gel. Community Dent Oral Epidemiol. 1976 Jul;4(4):133-6.

Application methods not currently used in practice

Pochanugool L, Manomaiudom W, Im-Erbsin T, Suwannuraks M, Kraiphibul P. Dental management in irradiated head and neck cancers. J Med Assoc Thai. 1994 May;77(5):261-5.

Head-to-head

Gallagher SJ, Glassgow I, Caldwell R. Self-application of fluoride by rinsing. J Public Health Dent. 1974 Winter;34(1):13-21.

Product concentrations not available commercially

Heifetz SB, Driscoll WS, Creighton WE. The effect on dental caries of weekly rinsing with a neutral sodium fluoride or an acidulated phosphate-fluoride mouthwash. J Am Dent Assoc. 1973 Aug;87(2):364-8.

0.3% NaF and APF; product concentrations not available commercially

Petersson LG, Arthursson L, Ostberg C, Jönsson G, Gleerup A. Caries-inhibiting effects of

different modes of Duraphat varnish reapplication: a 3-year radiographic study. Caries Res.

1991;25(1):70-3.

Head-to-head

varnish frequency

trial; no control

Weinstein P, Spiekerman C, Milgrom P Randomized equivalence trial of intensive and semiannual

applications of fluoride varnish in the primary dentition. Caries Res. 2009;43(6):484-90. Epub 2009

Dec 10.

Head-to-head

varnish frequency

trial; no control

Seppä L, Tolonen T. Scand J Dent Res. Caries preventive effect of fluoride varnish applications

performed two or four times a year. 1990 Apr;98(2):102-5. Head-to-head

varnish frequency

trial; no control

Axelsson P, Paulander J, Nordkvist K, Karlsson R. Effect of fluoride containing dentifrice, mouthrinsing, and varnish on approximal dental caries in a 3-year clinical trial. Community Dent Oral Epidemiol. 1987 Aug;15(4):177-80.

0.7% F

Fluorprotector

composition no

longer available

van Eck AA, Theuns HM, Groeneveld A. Effect of annual application of polyurethane lacquer containing silane-fluoride. Community Dent Oral Epidemiol. 1984 Aug;12(4):230-2.

0.7% F

Fluorprotector

composition no

longer available

Demito CF, Rodrigues GV, Ramos AL, Bowman SJ. Efficacy of a fluoride varnish in preventing

white-spot lesions as measured with laser fluorescence. J Clin Orthod 2011;45(1):25-9; quiz 40.

Split mouth; 6

month data and

only white spot

lesions (not frank

cavitation)

Milgrom PM, Tut OK, Mancl LA. Topical iodine and fluoride varnish effectiveness in the primary

dentition: a quasi-experimental study. J Dent Child (Chic) 2011;78(3):143-7. Varnish + iodine

vs. varnish alone,

no placebo group

(head to head)


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Lepp%C3%A4nen%20T%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bruun%20C%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Bille%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Hansen%20KT%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kann%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Qvist%20V%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Thylstrup%20A%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Franchi%20GJ%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Mosley%20GW%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Fl%C3%B3rio%20FM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Pereira%20AC%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Meneghim%20Mde%20C%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ramacciato%20JC%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Shern%20RJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Duany%20LF%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Senning%20RS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Zinner%20DD%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Pochanugool%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Manomaiudom%20W%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Im-Erbsin%20T%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Suwannuraks%20M%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kraiphibul%20P%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gallagher%20SJ%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Glassgow%20I%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Caldwell%20R%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Driscoll%20WS%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Creighton%20WE%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Arthursson%20L%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Ostberg%20C%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22J%C3%B6nsson%20G%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Gleerup%20A%22%5BAuthor%5D



http://www.ncbi.nlm.nih.gov/pubmed?term=%22Weinstein%20P%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Spiekerman%20C%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Milgrom%20P%22%5BAuthor%5D




http://www.ncbi.nlm.nih.gov/pubmed?term=%22Tolonen%20T%22%5BAuthor%5D


http://www.ncbi.nlm.nih.gov/pubmed?term=%22Paulander%20J%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Nordkvist%20K%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Karlsson%20R%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22van%20Eck%20AA%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Theuns%20HM%22%5BAuthor%5D

http://www.ncbi.nlm.nih.gov/pubmed?term=%22Groeneveld%20A%22%5BAuthor%5D



80

Neumann AS, Lee KJ, Gussy MG, et al. Impact of an oral health intervention on pre-school children

< 3 years of age in a rural setting in Australia. J Paediatr Child Health 2011;47(6):367-72. Concentration of

fluoride in

toothpaste not

reported

Patil YB, Hegde-Shetiya S, Kakodkar PV, Shirahatti R. Evaluation of a preventive program based

on caries risk among mentally challenged children using the Cariogram model. Community Dent

Health 2011;28(4):286-91.

Combination of

therapies tested

based on

Cariogram risk

assessment

Wong MC, Lam KF, Lo EC. Analysis of multilevel grouped survival data with time-varying regression coefficients. Stat Med 2011;30(3):250-9.

Fluoride-related

data reported

previously

Divaris K, Rozier RG, King RS. Effectiveness of a school-based fluoride mouthrinse program. J

Dent Res 2012;91(3):282-7. Retrospective

Everett E. Fluoride and caries. Eur J Oral Sci 2011;119 Suppl 1:25-31. Not a trial

Guzman-Armstrong S, Chalmers J, Warren JJ. Ask us. White spot lesions: prevention and

treatment. Am J Orthod Dentofacial Orthop 2010;138(6):690-6. Not a trial

Karademir S, Akcam M, Kuybulu AE, Olgar S, Oktem F. Effects of fluorosis on QT dispersion, heart

rate variability and echocardiographic parameters in children. Anadolu Kardiyol Derg

2011;11(2):150-5.

Not topical

fluorides

Keim RG. Preventing and treating white-spot lesions. J Clin Orthod 2011;45(1):9-10.

Editorial / Not a

trial

Slade GD, Bailie RS, Roberts-Thomson K, et al. Effect of health promotion and fluoride varnish on

dental caries among Australian Aboriginal children: results from a community-randomized

controlled trial. Community Dent Oral Epidemiol 2011;39(1):29-43.

Co-intervention in

experimental arm

that control did

not have

81

Appendix 4 – Study characteristics, bias scores, and outcomes data tables

Table A: Characteristics of studies on 2.26% fluoride varnish

Citation Age Country Special

Population?

Intervention (Dose/duration/frequen

cy) Control

Prior prophylaxis

?

Caries risk

status as stated by authors

Baseline score

Other F exposure for both groups

Specifically recruited

patients with caries experience

?

Follow-up

duration

Outcome measure

Diagnostic criteria

Reported result

Adverse events

Study Design

Primary Dentition Autio-

Gold 2001 35

3 – 5 years

US Children Duraphat every 4

months No Tx

No prophylaxis

Low SES dmfs >

2.5; dmft > 1.98

0.8 ppm water F,

toothpaste No 9 months

dmfs, dmft, ds

Cavitated Significant favoring F

Not assessed

RCT

Clark 1985

31-33

7 Canada Children 1. Durafluor 2.

Fluorprotector every six months

No varnish

Professional Prophylaxis

Not Stated

DMFS < 1;

Baseline dfs not given

Dentifrices, supplemet

s and topical fluoride

No 32

months

DMFS – all teeth and all

surfaces dfs – only first and second molars

Cavitated Significant favoring varnish

Not assessed

RCT

Grodzka 1982

40

3 - 4 Poland Children Duraphat every 6

months No

treatment Pumice

prophylaxis Not stated

dmfs1 > 10

dmfs2>9.3 dmft1>6.5 dmft2>6.3

No topical fluorides

No 2 years

dmfs and dmft – all teeth and surfaces

Cavitated WSL

Significant favoring

Duraphat for WSL dmft

ONLY

Not assessed

GCCT (not adjusted for clustering)

Gugwad, 2011

39

6-7 years

India No

(children)

Cavity Shield (reportedly 5% NaF); 3 times a

week (once every two days in a week), once a

year; OHI at baseline

No treatment; OHI at baseline

Yes Not stated

defsp 5.3-5.5

defs 5.6-5.7

DMFS=0.4-0.7

Primary

defs Control:

5.63 Varnish:

5.67 p=0.95

Not reported

No 1 year

deft and defs; deftp and defsp

for posterior teeth;

DMFT and DMFS

WHO criteria,

including bitewings

Primary defs Control:

6.52 Varnish:

4.68

Increments Control:

0.89 Varnish: -

0.99 p=0.03

Statistically

favors varnish for

primary teeth/surfaces and no difference

for permanent teeth/surfac

es *Note that in

discussion

Not reported

RCT

82

section the authors note

that many children did

not have erupted molars,

which may have

affected the permanent

teeth results

Hardman 2007

36

6-8 United

Kingdom Children

Duraphat every 6 months

No varnish

Unclear

Not stated

“Relatively deprived communit

y”

“Prevalence and

severity of caries…is among the

worst in the

country”

d3ft > 2 dfs not given

F milk; Fl toothpaste

Non-

fluoridated community

No (but post-hoc

per baseline score)

26 months

dfs – primary

molars all surfaces

WS and cavitated

Non-significant difference for large WSL and dentine lesions;

significant for small

WSL

Not assessed

GRCT (adjusted)

Holm 1979

41

3 Sweden Children Duraphat every six

months No

treatment

Brushing with special

powder Not stated ds < 1.5

F toothpaste; Some had

Fl supplemen

ts

No 2 years defs – All

teeth

Cavitated and WSL separatel

y

Significant favoring Duraphat

Not assessed

CCT

Lawrence 2008

37

6 months

to 5 years

Canada Children Duraflor every 4- 6

months + counseling

Caregiver Counselin

g Unclear

High-risk (aboriginal children)

dmft > 6 No F water No 2 years dmfs – all

teeth and all surfaces

All stages Significant favoring F

varnish

None reported; one child allergic to

lanolin

GRCT (adjusted

data)

Weintraub 2006

38

6 – 44 months

US Children

low income

1. Duraphat + parental counseling 2x/year 2. Duraphat + parental counseling annual

Parental counselin

g

No

prophylaxis Not Stated ds = 0

F toothpaste

and F water

No (caries-free)

2 year dfs – all


Cavitated and all stages

Significant favoring varnish

None observed

RCT

Permanent Dentition

Arruda 2012

42 7-14 Brazil Children

Cavity Shield (5% NaF or 2.26% F); tested

application 1 and 2 times per year combined

Placebo varnish

Toothbrushing

None

DFS Test – 6.15

Control – 5.59

58.4% and 59.7% of Test and Control

received Fluoridated

water

No 12

months

DFS Prevented

fraction

ICDAS 1 and

above

Either 1 or 2 applications (combined)

stat sig better than placebo; post hoc analysis only 2

applications stat sig

better than placebo

None were reported; no participant removed owing to

complications

associated with varnish application

RCT

Bravo 1997

43, 44,

116

6 - 8 Spain Children Duraphat every 6

months No

varnish Unclear Not Stated DMFS < 1

Not investigate

d No

4 years (2 year

data available)

DMFS – first

permanent molar all surfaces

Cavitated Significant in favor of

varnish

Not assessed

GRCT (molar is the

unit of analysis and adjustment for this BUT allocation by

83

school class)

Clark 1985

31-33 7 Canada Children

1. Durafluor 2. Fluorprotector every six

months

No varnish


Not Stated

DMFS < 1;

Baseline dfs not given

Dentifrices, supplemet

s and topical fluoride

No 32

months

DMFS – all teeth and all

surfaces dfs – only first and second molars


Not assessed

RCT

Holm and Holst

1984 45

5 years and 9 month

s

Sweden Children Duraphat every 6

months No

treatment

Toothbrush with special cleansing

powder and water

Not Stated

dmfs > 8

NEWLY ERUPTING FIRST MOLARS DMFS=0

Weekly rinsing with 0.2% NaF, 0.4 – 0.9

ppm Water F

No

2 years after

eruption of

permanent first molar

DS - Occlusal

surfaces of first

permanent molars

Cavitated Significant Favoring F

varnish

Not assessed

RCT (patient was

unit of randomization but looks like results

are reported for molars)

Ibricevic 2005

53 6-15 Kuwait

Children (data for special needs

available)


No varnish

Unclear High SES

DMFT < 1 (Healthy) DMFT <

1.5 (Special needs)

Unclear No 2 years DMFT – all


Cavitated

Non-significant for healthy children;

Significant favoring fluoride

varnish for special needs

Not assessed

CCT

Koch 1975

46 15 Sweden

Adolescents


No treatment

Pumice prophylaxis

High risk DMFS >

20

F rinse every 2 weeks

No (post-hoc based on baseline

score)

1 year DMFS – all teeth and all

surfaces

Cavitated and WSL


(mainly for low and medium

risk)

Not assessed

RCT

Milsom 2011

47

7-8 yrs.

England School children

0.1ml Duraphat (5% NaF) 3 X yr. on

permanent 1st molars

Yes- no

treatment No High Risk No

No water fluoridation

No 3 yrs.

DFS (primary)

DFT (secondary)

cavitation

No statistically

different difference

between the groups

12 children in

intervention group

reported adverse reactions

(full details online)

GRCT; 95 clusters in

each tx

Modeer 1984

48 14 Sweden

Adolescents

Duraphat every three months

No treatment

Pumice prophylaxis

Not Stated DFS > 2

Weekly F rinse, Low F water; F toothpaste

s

No (post-hoc based on baseline

score)

3 years

DFS – premolars and molars

proximal surfaces

All stages,

Cavitated and WSL

Significant favoring varnish; different

with baseline risk

Not assessed

RCT

Skold 2005

49 13 Sweden Children

Duraphat every 6 months, 3 times a year

within one week, 8 times per year at 1 month

intervals during school year

No varnish

Self brushing without paste

Low, Medium and High based on

SES, caries and

water F

DFT – 0.6 – 2.65

Optimal water F in low risk

area. Low water F in medium and high

risk areas. 95% in all

groups were

No (Varied by SES

and water F)

3 years

DS – proximal surfaces

from distal of canine to

mesial of second molar

(radiographic)

All stages,

WSL and cavitated separatel

y


None observed

RCT

84

treated with one F varnish at the yearly check-up.

Fl toothpaste

Schaeken50

44.4 Netherlan

ds Adults


No varnish


Unclear > 60 root lesions

Varied Yes 1 year RCI All Stages Significant favoring varnish

None observed

RCT

Tagliaferro, 2011

54 6-8 Brazil Children Duraphat biannually

No varnish

No; Supervised

tooth brushing

Low and high risk

High risk dmft > 4.3; DMFT>0.2

6

Low risk dmfs +

DMFS=0

Fl water; Fl Tooth

paste Yes 2 years

DMFS permanent first molar

only

Cavitated and WSL

Not significant

Not assessed

CCT

Tan 2010

51 78.8

Hong Kong

Nursing home

residents

OHI + Duraphat every three months

OHI No

prophylaxis Not Stated

DFS (Root) > 2

Unclear No 3 years

RCI New

caries or fillings –

remaining teeth

Cavitated Significant favoring

NaF + OHI

None observed

RCT

Tewari 1990

52 9-12 India Children

2.26 % Duraphat for 4 min every 6 months

Placebo varnish of

double distilled water


Not Stated DMFS > 2 Low water

F No 2.5 years

DMFS and DMFT – all


All stages Significant

favors Varnish

Not assessed

RCT

Combined Dentition

Shobha 1987

55 9 - 12 India Children

Six monthly applications of Duraphat

No varnish


without F Not Stated

DMFS/dmfs > 10

Low water F

No 3 years DMFT/dmft; DMFS/dmfs – all teeth


Mild burning, pungent odor and

nausea with APF

CCT

85

Table B: Risk of bias assessment of studies on 2.26% fluoride varnish

Citation Risk of

bias score

Were patients in both arms recruited from the

same population

at the same time?

Randomization claimed (random

sequence generation)

Randomization procedure described

Allocation concealment

(selection bias, protects

assignment sequence

before and until allocation)

Blinding (ascertainment bias, protects

sequence after allocation) –

Examiner, patient and statistician)

Rate of losses to follow-up similar

between tx groups

Baseline caries

status of those lost to

follow-up similar to

those remaining

Baseline caries status similar between tx

groups at end of study or

adjustment for confounding

Sample size

estimated apriori

Intention to treat used?

Conflict of

Interest absent?

Primary Dentition

Autio-Gold 2001

35

6 Yes Yes No Yes Yes Yes Unclear Unclear No No Yes

Grodzka 1982

40

2 Yes No No No No Unclear Unclear Unclear No No Yes

Gugwad 2011

39

4 Yes Yes No No Unclear Yes Unclear Unclear Unclear Unclear Yes

Hardman36

7 Yes Yes Yes Unclear Examiner Yes Unclear Yes Yes No No

Holm 1979

41

5 Yes No No No Examiner Yes No Yes No No Yes

Lawrence 2008

37

9 Yes Yes Yes Unclear Examiner Yes (ITT) Unclear Yes Yes Yes Yes

Weintraub 2006

38

11 Yes Yes Yes Yes

Examiner and patient

Yes Yes Yes Yes Yes Yes

Permanent Dentition

Arruda42

8

Yes Yes Yes No Examiner and

patient Yes Unclear Yes Yes No Yes

Bravo43, 44,

116

5 Yes Yes No Unclear Examiner Unclear Unclear Yes No No Yes

Clark31-33

7

Yes Yes No Unclear Examiner and

patient Yes Yes Yes No No Yes

Holm and Holst

45

4 Yes Yes No Unclear Unclear Unclear Unclear Yes No No Yes

Ibricevic 2005

53

2 Yes No No No No Unclear Unclear Unclear No No Yes

Koch 1975

46

4 Yes Yes No No unclear

Yes (min LOF)

Unclear Unclear No Unclear Yes

Milsom 2011

47

10 Yes Yes Yes Yes Yes Yes Unclear Yes Yes Yes Yes

Modeer 1984

48

5 Yes Yes No No Examiner No Unclear Yes No No Yes

Skold 2004

49

6 Yes

Yes within cohorts

Unclear Unclear Provider and

examiner Yes Unclear Yes No No Yes

Schaeken50

7 Yes Yes No Unclear Patient and Yes (no Yes Yes No NA No

86

examiner loss)

Tagliaferro, 2011

54

7 Yes No No No Examiner Yes Yes Yes Yes No Yes

Tan 201051

11 Yes Yes Yes Yes Examiner Yes Yes Yes Yes Yes Yes

Tewari 1990

52

7 Yes Yes No Unclear Examiner

Yes (min loss)

Yes Yes No No Yes

Combined Dentition

Shobha 1987

55

6 Yes No No Unclear No

Yes (min loss)

Yes Yes No NA Yes

Table C: Outcomes data from studies on 2.26% fluoride varnish

Citation Outcome measure (permanent/primary;

surfact/tooth; outcome; all stages/ws/cavitated)

Exp mean

Exp SD Exp n Control mean

Control SD Control

n Other available data

Primary Dentition

Autio-Gold 2001 35

Caries prevalence dmfs – cavitated – 9-

month data 3.05 4.25 59 4.05 4.40 83

Use Table 1 data (cavitated); 9-month data;

Data for all stages including WSL available (in Table 2)

Caries increment dmfs – cavitated –

calculated (baseline to 9 months) 0.54 4.1 59 1.47 4.0 83

Caries increment dmft – cavitated – 9-

month data 1.68 2.27 59 2.57 2.28 83

Clark Cavitated increment assumed dfs – 32

months 1.49

2.36 245 2.06

2.82 234

SD calculated from Cochrane equation in Clark 1985; noted difference not stat sig

Grodzka 1982 40

Net dmfs increment - cavitated 6.35 4.98 148 6.71 5.22 100

Radiographic data.

Net dmft increment - cavitated 2.04 1.98 148 2.46 2.13 100

Net dmfs increment – WSL 6.24 4.75 148 6.89 5.08 100

Net dmft increment – WSL 1.91 2.04 148 2.51 2.20 100

Gugwad 201139

defs, 1 year BEFORE 5.67 5.40 106 5.63 4.02 105

OHI-S; deftp, deft, DMFT

defs, 1 year AFTER 4.68 4.95 106 6.52 7.31 105

87

defs, change (calculated) -0.99 5.2 106 0.89 6.3 105

Hardman 200736

dfs caries increment – WSL (d1fs) 0.71 1.57 334 1.12 2.02 330 MA; wsl = d2fs+d1fs; proportion of children with caries

increment in permanent dentition

dfs caries increment – cavitated (d3fs) 1.52 2.39 334 1.49 2.36 330 calculated SD using Cochrane equation

already adjusted for clustering

Holm 197941

Net defs increment-Cavitated 2.10 2.75 112 3.74 4.62 113

Surface specific data; prevalence data in table 4

Net WSL(primary, surface) increment 0.81 2.56 112 0.92 3.07 113

Lawrence 200837

Mean net caries increment – dmfs all stages; Adjusted means, Aboriginal

children only 11.00 31 832 13.48 31 328

Unadjusted means available for intent-to-treat population; stratification by age group.

SD calculated from adjusted difference column in Table 3 of paper according to

SD = SE/(sqrt(1/832 + 1/328))

Weintraub 2006 38

dfs Incidence – cavitated – ITT group, 2x/year

0.7 2.1 87 1.7 3.1 100

1 application over 2 years; 3-4 applications over 2 years; Intended treatment group

dfs incidence- all stages – ITT group 2x/year

1.4 3.1 87 2.7 3.4 100

Permanent Dentition

Arruda42

DFS increment, one and two

applications combined 4.61

95% CI (3.54-5.67)

Calculated 4.39

113 7.72

(6.26-9.18)

Calculated 5.84

97

Prevented fraction, adjusted and unadjusted generalized linear models

Children who received one or two applications

SD calculated from Cochrane equation

Bravo 1997 43, 44, 116

DMFS caries increment – fissure cavitated)

1.33 1.82 98 2.13 2.06 116 Fissured vs non-fissured surfaces

DMFS caries increment – smooth (cavitated)

0.15 0.83 98 0.45 1.22 116 Fissured vs non-fissured surfaces

Calculated: Total fissure and smooth DMFS caries increment, cavitated

1.48 1.53 98 2.58 1.89 116 Fissure and smooth means added; SD for sum increment calculated via: Cochrane formula for

combining groups

88

CLUSTER ADJUSTED (all significant at all adjustments; picked conservative

ICC=0.2) 1.48 1.53 27 2.58 1.89 32 Used this in MA

Clark 198531-33

DMFS caries increment Duraflor-

Cavitated assumed 2.43 3.7 246 3.11 3.7 234

Surface specific data; 32 month data used but 56 month data available

SD calculated from p value in Clark 1985

Holm and Holst 1984 45

DS of first molars; Assumed prevalence, Cavitated

DECIDED SHOULD BE TOOTH-LEVEL DATA SINCE ONLY 1 SURFACE

1.44 2.32 50 3.29 3.65 59

Proximal only, occlusal only, depth of fissure, time to caries from eruption

Use Cochrane regression equation to impute SD

Ibricevic 200553

DMFT caries increment - cavitated 0.35 0.69 43 0.47 1.13 34 Special Needs

Koch 197546

Net DMFS increment cavitated 0.9 3.80 60 4.0 3.75 61 By baseline prevalence and surface specific data

available. By caries risk also available. Net WSL (surface) increment 0.5 3.56 60 1.3 2.58 61

Milsom 201147

DFS mean cavitated increment

DFT mean cavitated increment

DFS 0.65 DFT 0.36

2.15 0.91

1270 DFS 0.67 DFT 0.35

2.10 0.90

1320

Cluster DFS data 0.66 0.73 94 0.63 0.66 95

Cluster DFT data 0.36 0.35 94 0.33 0.30 95

Modeer 1984 48

DFS increment – cavitated [03+F] (by

subtracting prevalence at baseline from

prevalence at 3 years)

1.4 2.3 87 2.0 2.8 107

Scores separately for each stage available; progression data available; Progression data by caries

acitivity

SD for increment imputed via Cochrane regression equation (2009)

Used in MA – 3-year DFS (proximal

surfaces on premolars and molars)

Decayed 03 plus Filled

2.5 3.1 87 3.7 3.9 107 Baseline not subtracted to be consistent with other

studies (Autio-Gold and Petersson 1991); Cochrane regression equation for SD

Skold 200449

Permanent approximal surface-Caries

incidence – all stages, application frequency = every 6 months

0.79 1.67 190 1.85 2.89 181 By risk category; by different intervals and caries

prevalence by WSL and cavitated

89

Schaeken 1991 50

Root Caries increment surface cavitated 0.67 0.80 15 1.54 0.80 13 Calculated from p value in paper

Tagliaferro, 201154

Caries increment DMFT cavitated (high

risk) Occlusal surfaces only 0.29 0.68 48 0.39 0.72 44

WSL data available; combined data available

Caries increment DMFT all stages (high

risk) – Occlusal surfaces only 0.31 0.69 48 0.27 0.90 44

Caries increment DMFT cavitated (low

risk) Occlusal surfaces only 0.09 0.29 43 0.12 0.40 42

Caries increment DMFT all stages (low

risk) – Occlusal surfaces only 0.09 0.29 43 0.14 0.42 42

Caries increment all risks, all surfaces 0.33 1.04 91 0.57 1.39 86

Tan 201051

Caries incidence – Root-Cavitated root

surfaces 0.9 2.10 49 2.5 3.71 55

Tewari 199052

DMFS – caries increment - all stages 0.554 4.58 311 2.163 4.12 307 Surface specific data; Teeth present at baseline vs

erupted during study DMFT – caries increment - all stages 0.383 2.61 311 1.47 2.26 307

Combined Dentition

Shobha 198755

DMFT + dmft – caries increment– all stages – at 3 years

3.72 1.99 195 6.89 3.33 195

DMFS + dmfs – caries increment– all stages – at 3 years

5.55 2.53 195 10.36 3.86 195

90

Table D: Characteristics of studies on 0.1% fluoride varnish


Population?

Intervention

(Dose/duration/frequency) Control

Prior

prophylaxis?

Caries

risk

status as

state d

by

authors

Baseline

score

Other F

exposure for

both groups

Specifically

recruited

patients with

caries

experience?

Follow-

up

duration

Outcome

measure

Diagnostic

criteria

Reported

result

Adverse

events

Study

Design

Zimmer

200158

9 –

12

years

Germany Children

Fluorprotector every 4

months + oral hygiene

instruction

Oral

hygiene

instruction

Professional

Fluoridated

prophylaxis

paste

High-risk

dmft and

DMFT >

0

Unclear Yes 2 years DMFS

WSL, All

stages and

Cavitated

Significant

for smaller

lesions

Not

assessed RCT

Twetman 1996

57

4 - 5 Sweden Children Fluorprotector every 6

months No varnish

Pumice prophylaxis

Not low risk

dfs 0.18-1.0

0.1 ppm water F, used F toothpaste and some got

F tabs

No 2 years dfs, dft,

dfsa Cavitated

Significant favoring F

Not assessed

GCCT

Petersson

1998 56

4 - 5 Sweden Children

Fluorprotector every 6

months No varnish

Pumice

prophylaxis

and floss

Low

caries

risk

dfs>1

0.1 ppm

water F for

most; 10% in

1.2 ppm F

area, used F

toothpaste

and some got

F tabs

No 2 years dfs Cavitated Not

significant

Not

assessed GCCT

91

Table E: Risk of bias assessment of studies on 0.1% fluoride varnish

Citation Summary

risk of bias score


same population at

the same time?






assignment sequence

before and until allocation)





between tx groups

Baseline caries



those remaining




Sample size

estimated apriori


Conflict of

Interest absent?

Zimmer 2001

58

6 Yes Yes Yes Unclear Unclear No Yes Yes Unclear No Yes

Twetman 1996

57

2 No No No No Unclear

Yes (min loss)

Unclear Unclear No No Yes

Petersson

1998 56

2 No No No No Unclear No Yes Unclear No No Yes

Table F Outcomes data from studies on 0.1% fluoride varnish

Citation Outcome measure (permanent/primary;

surface/tooth; outcome; all stages/ws/cavitated)

Exp mean

Exp SD Exp n Control mean

Control SD

Control n

Other available data

Zimmer 200158

Mean increment – DMFS All stages 6.18 3.92 187 9.14 4.50 131

Prevalence data available Mean increment – DMFS WSL 3.96 4.97 187 6.53 5.71 131

Mean increment – DMFS Cavitated 2.22 2.49 187 2.61 2.85 131

Twetman 199657

Caries incidence – dfs--Cavitated 1.07 1.96 442 1.53 2.55 374

Approximal data; high F area

Caries incidence - dft--Cavitated 0.65 1.40 442 1.09 1.85 374

Petersson 1998 56

Caries incidence – dfs--Cavitated 1.30 2.46 2245 1.39 2.66 1916 Approximal data

92

Table G: Characteristics of studies on professionally-applied 1.23% fluoride (APF) gel


Population?

Intervention (Dose/duration/

frequency) Control

Prior Prophyl

axis

Caries risk

status as state d by authors

Baseline score

(approximate)

Other F exposur

e for both

groups

Specifically recruited patients

with caries experience

?

Follow-up duration

Compliance

Outcome measure

Diagnostic criteria

Reported result

Adverse events

Study Design

Agrawal 2011

70

9-16 years; mean age

experimental

group was

12.83, and

control was

12.94

India

High risk school

children (underprivil

eged)

1.23% APF gel (Fluorovil) + oral health education at baseline; gel

applied at baseline and 6 months for 4

minutes

No intervention + oral

health educatio

n at baseline

Assume No

“High risk”; “underprivileged”; “low

SES”

4.01 for gel

group; 4.30 for control (DMFS)

Few regularly

using fluoride

dentifrice

Yes

6 and 12

months

Professionally applied

DFMT, DMFS, IL (incipient lesion)

All stages

No statistically significant

differences at 12 months in

cavitated data; (statistically significant difference,

improvement for gel group, in IL at 6 and 12

months)

None were

reported

GRCT, n=1

cluster per

intervention

Jiang and Tai 2005

65

6 – 7 China Children 1.23% APF for 4 minutes gel every

6 months No Tx

No professio

nal prophyla

xis

Not Stated DMFS >

7 Low

water F No

2 years

Professional

application

DMFS – first molar

Cavitated

Significant favoring F for

smooth surfaces only

None observed

GRCT (by class and not

adjusted)

Hagan 1985

63

11 - 15 Unites States

Children 1.23% APF gel for 4 minutes

every 6 months

Placebo gel (no F or acid)

Professional brush and floss with no paste

Not stated DMFS >

4

Low water F; Some

children received professio

nally applied fl

from regular dentists

No 2

years

Professional

application

DMFS – all teeth

Cavitated Statistically significant favoring F

3 episodes

of nausea

or vomiting

RCT

Trubman 1973

68

8.12 United States

Children

1.23% APF gel for 4 minutes +

nonfluoride prophylaxis paste four times during

school year

Placebo gel (non

F) + nonF

prophy paste

Self brushing

with prophylaxis paste

Not Stated DMFS >

2 Low

water F No

3 years

Self-applied

at school

DMFT, DMFS – all

teeth Cavitated


Not assesse

d RCT

Horowitz 1968, 1969,

197172-74

10-12 (grades

5-6)

United States

Children 1.23% APF gel for 4 minutes

annually Prophy

Prophy with

standard paste (no fluoride)

Unclear DMFS >

8 Low

water F No

3 years


DMFS –all teeth


None observed

CCT

Bryan 1968

59,

1970 60

8 - 12

United States

Children

Single application of Phosphate fluoride gel

(1.23% APF) for 4 minutes +

prophylaxislaxis

Prophy Prophy Unclear DMFS >

5 Low

water F No

2 years


DMFS, DMFT – all

teeth Cavitated


Not assesse

d RCT

93

Ingraham 1970

64

6 - 11 United States

Children

1. prophylaxis + APF gel for 4

minutes single application

No treatmen

t Prophy Unclear

DMFS > 2

Low water F; Unclear

dentifrice exposure

No 2

years


DMFS, DMFT – all

teeth Cavitated


Not assesse

d RCT

Cons 1970 62

6 - 11

Unites States

Children

1.23% APF gel for 4 minutes+

prophylaxis annually

Prophy+ water

Pumice Prophy

Unclear DMFS >

2 No water

F No

3 years


DMFS, DMFT - all teeth and surfaces for 1M

Cavitated Significant

favoring APF

Not assesse

d RCT

Wallace 1993

69

60 United States

Seniors

1.2 % APF gel for 4 minutes (Luride) +

placebo rinse semi-annual

Placebo rinse

Yes-sonic scaler

Unclear (root

caries prevalence of 69.7%)

DS > 1

F water and F

toothpaste

No 4

years


Root caries DMFS (Katz)


Not assesse

d RCT

Olivier 1992

67 6 Canada Children

1.23% APF 4 minute gel bi-

annual (every 6 months)

Non-F Placebo

gel

No

prophyla

xis High-risk defs > 20

F Toothpas

te

Yes (High and very-

high)

2 years


DMFS – all teeth

All stages Not significant Not

assessed

RCT

Cobb 1980 61

11 - 14 US Adol-

escents

1.23% APF gel 4 minutes every 6

months

No treatmen

t

Professional

brushing/floss

Unclear DMFS >

5 Low

water F No

2 years


DMFS – all teeth

Cavitated Significant Favoring F

Not assesse

d RCT

Shobha 1987

55 9 - 12 India Children

Semi-annual applications

of1.23% APF gel No gel

Professional

prophylaxis with nonF paste

Not Stated DMFS/dmfs >10

Low water F

No 3

years


DMFT/dmft;

DMFS/dmfs – all teeth

Cavitated

Significant favoring Naf

and APF compared to

control

Mild burning, pungent odor and nausea

with APF

CCT

Andruskeviciene 2008

71

3 - 7 Lithuani

a Children

Toothbrushing with F paste OR 1.23% APF gel every 4 months

No tx Unclear Unclear dmft > 3 F

toothpaste

No 3

years


dmft and dmfs

Cavitated Significant

favoring APF

Not assesse

d CCT

Mainwaring 1978

66 11 - 12 UK Children

1.23% APG gel semi-annually for 4 min + brushing with NonF paste

NonF Gel +

brushing with no-F

paste

Self-brushing

Unclear DFS > 5 Water F

< 0.3ppm No

3 years


DFS – all teeth and surfaces

cavitated Significant favoring F

Not assesse

d RCT

Szwejda 1971

75 7 - 8 US Children

1.23% APF annual for 3

minutes No gel

Pumice prophyla

xis Unclear DFS < 2 No No

2 years


DFT, DFS – all teeth

and surfaces

Cavitated Nonsignificant Not

assessed

CCT

94

Table H: Risk of bias assessment of studies on professionally-applied 1.23% fluoride (APF) gel

Citation Summary risk of bias score

Were patients in both arms

recruited from the same

population at the same

time?






assignment sequence before

and until allocation)

Blinding (ascertainment bias, protects sequence after allocation) – Examiner, patient and statistician)

Rate of losses to follow-up

similar between tx

groups

Baseline caries status of those lost to follow-up

similar to those

remaining




Sample size estimated

apriori


Conflict of Interest absent?

Agrawal 201170

7 Yes Yes Yes Unclear Examiner Yes Unclear Yes No No Yes

Jiang 2005 65

7 Yes Yes Yes No Examiner No Unclear Yes Yes No Yes

Hagan 198563

7 Yes Yes No Unclear Examiner and


Trubman 1973 68



Horowitz 1968, 1969, 1971

72-74

7 Yes Yes Yes No Unclear Yes Yes yes No No Yes

Bryan 1969, 1970 60

6 Yes Yes Yes Unclear Unclear Unclear Yes Yes No No Yes

Ingraham 1970 64

6 Yes Yes No unclear Examiner Yes unclear Yes No No Yes

Cons 1970 62

7 Yes Yes No Unclear Examiner Yes Yes Yes No No Yes

Wallace 1993 69

6 Yes Yes No Unclear Examiner Yes Unclear Yes No No Yes

Olivier 1992 67

7 Yes Yes No No Provider and

examiner Yes Yes Yes No No Yes

Cobb 1980 61

5 Yes Yes No Unclear Examiner Yes Unclear Unclear No No Yes

Shobha 198755

5 Yes No No Unclear No Yes (min

loss) Yes Yes No No Yes


71

4 Yes No No Unclear Unclear Yes (min

loss) Unclear Unclear No NA Yes

Mainwaring 1978

66


patient unclear Unclear Yes No No Yes

Szwejda 197175

3 Not clear Not stated No No Examiner Not

stated Not stated Yes No No Yes

95

Table I: Outcomes data from studies on professionally-applied 1.23% fluoride (APF) gel

Citation Outcome measure Exp mean Exp SD Exp n Control mean Control SD Control n Other available

data

Primary Dentition


71

dmft increment cavitated

0.55 0.43 118 1.41 0.94 137

dmfs increment cavitated

0.68 0.65 118 1.92 0.94 137

Permanent Dentition

Agrawal 201170

DMFS – as reported

(12 months) 4.32 1.439 120 4.63 1.484 119

IL data, 6 month data

Jiang and Tai 2005

65

Mean DMFS increment –cavitated

0.38 0.69 200 0.50 0.87 221 Smooth surface

and P and fissure reported

Hagan 198563

Mean DMFS

increment cavitated 3.08 3.85 108 4.40 3.86 103

Smooth surface and P and fissure

reported

Trubman 1973 68

Mean DMFS increment cavitated

2.74 3.13 145 4.21 4.12 166

Reversals Mean DMFT

increment cavitated 1.29 1.57 145 1.67 1.67 166

Horowitz 1968, 1969, 1971

72-74

Mean DMFT increment cavitated

3.06 2.97 182 3.62 3.00 170

Surface type; reversal


6.51 6.75 182 8.61 7.95 170

Bryan 1969, 1970 60


2.01 2.54 103 3.63 3.33 105


4.56 4.50 103 7.26 4.76 105

Ingraham 1970 64


1.84 2.24 56 3.13 2.70 63


0.84 1.05 56 1.76 0.79 63

Cons 1970 62

Mean DMFT increment Cavitated

1.50 1.67 278 1.99 1.94 311

Mean DMFS increment - Cavitated

3.14 3.83 278 3.82 5.11 311

96

Wallace 1993 69

DMFS increment-

Cavitated 0.27 2.71 147 0.91 2.99 171

Reversed lesions, new lesions

Olivier 1992 67

DMFS increments –

All stages 2.94 3.09 224 3.24 3.13 207

Surface level data available

Cobb 1980 61

DMFS increment –

cavitated 5.28 0.66 115 8.15 0.87 78

Shobha 198755

DMFT + dmft – Caries Increment- all

stages 4.86 2.58 195 6.89 3.33 195

DMFS + dmfs caries increment – all

stages 7.45 3.01 195 10.36 3.86 195

Prevalence data available

Mainwaring 197866

Net DFS increment

cavitated 7.10 5.62 315 8.27 6.62 316 Reversals

Szwejda 197175

Caries incidence DMFT cavitated

1.23 1.22 148 1.27 0.75 170

Caries Incidence DFS Cavitated

2.07 2.43 148 2.15 2.22 170

Table J: Characteristics of studies on 1.23% fluoride (APF) foam


Population?


frequency) Control

Prior prophylaxis?

Caries risk

status as

stated by

authors

Baseline score

(approximate)



with caries experience?

Follow-up

duration Compliance

Outcome measure

Diagnostic criteria

Reported result

Adverse events

Study Design

Jiang and Tai 2005

65

6 – 7 China Children

1.23% APF Foam for 4

minutes every 6 months

No Tx No

prophylaxis Not

Stated DMFS > 7

Low

water F No 2 years

Professional application

DMFS – first

molar Cavitated

Significant favoring F for smooth surfaces

only

None observed

GRCT (by class and not

adjusted)

Jiang and Bian

200577

3-4 years

China Children

1.23% APF foam for 4

minutes every 6 months

Placebo No

prophylaxis Not

Stated dmfs > 2

22% F toothpaste; low water

F; no community programs

No 2 years Professional application

dmfs – all teeth and

all surfaces

Cavitated

Significant favoring

approximal surfaces

only

None observed

GRCT (p values at cluster level)

97

Table K: Risk of bias assessment of studies on 1.23% fluoride (APF) foam

Citation Summary risk of bias

score

Were patients in both arms recruited from

the same population at the same time?












similar between tx

groups

Baseline caries status of those lost to follow-up similar to

those remaining




Sample size estimated

apriori



Jiang and Tai 2005

65

7 Yes Yes Yes No Examiner No Unclear Yes Yes No Yes

Jiang and Bian

200577

9 Yes Yes Yes Yes Examiner and

patient Yes Unclear Yes Yes No Yes

Table L: Outcomes data from studies on 1.23% fluoride (APF) foam


data

Jiang and Tai 2005

65

DMFS increment – permanent first molar cavitated

0.39 0.65 191 0.50 0.87 221 Smooth surface

and Pit and fissure caries

Jiang and Bian 2005

77

dmfs Increment Cavitated

3.8 0.9 167 5.0 1.0 151 By tooth surfaces

98

Table M: Characteristics of studies on prophylaxis pastes containing fluoride


population? Intervention (Dose/duration/

frequency) Control

Caries risk

status as

stated by

authors

Baseline score

(approximate)


Subjects included based on

presence of caries

experience?

Follow-up

duration

Outcome measure (record smooth vs. pit

and fissure)

Diagnostic criteria

Reported result

Adverse events

Study Design

Peterson 1969

80


Children APF paste applied annually with a

rubber cup

Annual pumice

prophylaxis Unclear DMFS >4

Two data sets with

fluoridated and non-

fluoridated communities

No 2 years

DMFS, DMFT – all teeth

and surfaces

Cavitated Nonsignificant

difference Not

assessed RCT

Barenie 1976

81

9 - 14 Unites States

Children Semiannual prophylaxis with APF paste for 4 minutes for two years

Placebo paste

Unclear DMFS > 5 Low fluoride

area No 2 years

DMFS, DMFT, all teeth and

all surfaces


difference Not

assessed CCT

Schutze 1974

83

3 - 5 United States

Children APF paste (Luride) for 4 minutes

every 6 months

Pumice prophylaxis

every 6 months

Unclear defs > 2 Fluoridated

Water No 2 years

defs – all teeth and surfaces


difference Not

assessed CCT

DePaola 1973

79


Children

1.26% fluoride ion from ammonium fluorosilicate prophylaxis paste

(Luride) applied semiannually for 4 mins

Placebo paste

Unclear DFS > 6 Fluoridated dentifrice

No 2 years

DFS, DFT – all teeth and surfaces

Cavitated Significant difference favoring F

Not assessed

RCT

Horowitz 1966

82


Children 8.9% SnF prophylaxis paste for 4

minutes Lava

pumice Unclear DMFS > 5 Low water F No 2 years

DMFS, DMFT – all teeth

and surfaces


difference Not

assessed CCT

Beiswanger 1979

78


Children 9% SnF paste for 4 minutes +

placebo solution

Placebo paste + placebo solution

Unclear DMFS > 5

F dentifrice; Varying levels of natural water

fluoride levels

No 3 years

DMFS, DMFT – all teeth and all

surfaces


difference Not

assessed RCT

99

Table N: Risk of bias assessment of studies on prophylaxis pastes containing fluoride

Citation Summary risk of bias

score

Were patients in both arms recruited

from the same population at the

same time?





(selection bias, protects assignment sequence before and

until allocation)


sequence after allocation) – Examiner, patient and statistician)


between tx

groups

Baseline caries

status of those lost to follow-up similar to those

remaining

Baseline caries status

similar between tx groups at

end of study or

adjustment for

confounding

Sample size

estimated apriori


Conflict of

Interest absent?

Peterson 1969

5 Yes Yes No Unclear Yes Yes Unclear

Not Reported

No No Yes

Barenie 1976

4 Yes No No Unclear


Unclear Unclear Yes No No Yes

Schutze 1974 3 Yes No No No No Unclear Unclear Yes No No Yes

DePaola 1973

5 Yes Yes No Unclear


Unclear Unclear Yes No No Yes

Horowitz 1966 5 Yes No No Unclear Unclear Yes Yes Yes No No Yes

Beiswanger 1979

7 Yes Yes Yes Unclear

Examiner and Patient

Yes Unclear Yes No No Yes

100

Table O: Outcomes data from studies on prophylaxis pastes containing fluoride


data

Peterson 1969

Mean Increment DMFS Cavitated

Examiner A Fargo 2.63

3.14 256 3.00

4.37 252

Surface data; examiner B visual and x-ray; cannot combine data for

meta-analysis


Examiner B Fargo 2.31

2.75

256 2.72

3.73 252

Mean Increment DMFT Cavitated

Examiner A Fargo 1.66

1.87 256 1.80

2.02 252


Examiner B Fargo 1.36

1.76 256 1.68

1.97 252


Examiner A Moorhead

3.54 3.28

202 4.18 4.51

205


Examiner B Moorhead

2.47 4.05

202 2.93 4.01

205


Examiner A Moorhead

2.02 1.93

202 2.30 2.12

205


Examiner B Moorhead

1.34 1.71

202 1.55 1.92

205

Barenie 1976 Mean increment DMFS cavitated

examiner 1 7.67 7.16 181 7.15 6.07 152

Surface data; newly erupted,

reversals. Cannot

101

Mean increment

DMFS cavitated

examiner 2 5.30 6.38 179 4.93 5.26 150

combine data for meta-analysis

Mean increment

DMFT cavitated

examiner 1 3.98 3.50 181 3.78 2.98 152

Mean increment

DMFT cavitated

examiner 2 3.00 3.08 179 2.73 2.55 150

Schutze 1974 Mean increment defs cavitated

4.64 4.41* 20 4.04 4.09* 20

Surface, anterior vs posterior

*SD imputed using Cochrane equation

DePaola 1973

Mean increment DFT cavitated

2.36 2.15 151 2.92 2.68 169

Erupted;

Mean increment DFS cavitated

4.99 4.41 151 6.32 5.41 169

Horowitz 1966

Mean increment DMFT cavitated

1.63 NA 227 1.51 NA 222 Reversals

*Imputed using Cochrane equation

Mean increment DMFS cavitated

4.08 4.41* 227 3.85 3.98* 222

Beiswanger 1979

Mean Increment DMFT cavitated

2.87 3.42 139 3.46 3.68 141


4.47 6.25 139 5.26 7.01 141

102

Table P: Characteristics of studies on professional prophylaxis prior to fluoride application

Citation Age Countr

y Special

population?


frequency) Control

Caries risk status as stated by authors

Baseline score

(approximate)

Other exposure for both

groups


patients with caries

experience?

Follow-up

duration

Outcome measure

Diagnostic criteria

Reported result

Adverse events

Study Design

Ripa 1983, 1984

85, 86

10 - 14

United States

Children Professional Prophylaxis +

APF bi annual (data for self-prophylaxis available)

No prophyla

xis + APF

No Stated DMFS > 4 Low

water F No 3 years

DMFS, DMFT – all


Cavitated (Radike)

Nonsignificant difference

Not assessed

RCT

Houpt 1983 87

9 -13

United States

Children Professional Prophylaxis +

APF bi annual (data for self-prophylaxis available)

No prophyla

xis + APF

Not Stated DMFS > 2 0.2 ppm

water fluoride

No 2 years

DMFS, DMFT – all


Cavitated Nonsignificant difference

Not assessed

CCT

Johnston 1995

84

6 -11 Canada Children 1.23% APF gel biannual +

prophylaxis

No prophylaxis + bi annual APF

Very high risk defs > 10 Unclear Yes 3 years

defs + DMFS and defs – all


Cavitated Nonsignificant difference

Not assessed

RCT

103

Table Q: Risk of bias assessment of studies on professional prophylaxis prior to fluoride application

Citation Summary

risk of bias score

Were patients in both arms recruited from the same population at the

same time?






until allocation)



Rate of losses

to follow-

up similar

between tx

groups

Baseline caries


remaining

Baseline caries status similar

between tx groups at

end of study or

adjustment for

confounding

Sample size

estimated apriori



Ripa 1984

85

6 Yes Yes No Unclear Unclear Yes Yes Yes No No Yes

Houpt 1983

87

3 Yes No No No No Unclear Unclear Yes No No Yes

Johnston 1995

84

7 Yes Yes Yes Unclear


Unclear Unclear Yes Yes No Yes

104

Table R: Outcomes data from studies on professional prophylaxis prior to fluoride application

Citation Outcome measure

Exp mean Exp SD Exp n Control mean Control SD Control n Other data available

Ripa 1984 85

Mean DMFT increment Cavitated

2.02 2.35 324 2.01 2.14 314 Self-prophylaxis

and specific teeth surfaces

Mean DMFS increments Cavitated

3.33 4.35 324 3.19 3.62 314

Houpt 1983 87

Caries incidence – DMFS cavitated

2.05 3.4 269 2.14 3.4 381 Self-prophylaxis

Caries incidence – DMFT cavitated

0.94 1.6 269 1.19 1.8 381

Johnston 1995 84

defs increment cavitated

2.25 2.72 47 2.17 2.25 39

Biannual; defs+DMSF for 6-

7 year olds; Reversals in text

DMFS increment cavitated

2.22 3.13 45 2.50 2.40 30

105

Table S: Characteristics of studies on prescription-strength 0.5% fluoride (home-use) pastes


population?


frequency) Control

Prior prophylaxis? Make a note if Fluoride

prophylaxis paste was

used.


(record any risk

indicators)

Baseline caries

score for groups


Subjects included based on

presence of caries

experience?

Follow-up

duration

Outcome measure (record

tooth vs. surface,

smooth vs. pit and fissure)

(record if only

specific teeth

evaluated)

Diagnostic criteria

(cavitated only, All stages,

WSL only)

Reported result

(Statistical significance

of result)

Adverse events

Study Design#

Nordstrom 2010

88

14-16yr

Sweden adolescent

5000 ppm dentifrice

2yr 1gr 2Xday

Unsupervised

1450ppm dentifrice

no High DFS 5.84

5.83

0.1ppm water

F vanish tx 10%

supplements

yes 2yr DFS Cavitated

Enamel only

Favors 5000 ppm dentifrice

(p<0.01) compliant;

caries progression

(not incidence, p=0.4)

P=0.01 non-

compliant (progression);

p<0.05 (incidence)

For combined

groups (compliant and non-compliant) no difference in incidence

(p=0.08); favors 5000

ppm for progression (p<0.001)

Not described

Single blind RCT

Ekstrand 2008

89

75+ year olds; mean age 81.6

Denmark

Home-based frail elderly with active root caries

5,000 ppm F toothpaste 2x/day/pea size amount / unsupervised

1450 ppm F toothpaste 2x/day/pea size amount

F Varnish group has their teeth

brushed by a dental

hygienist before

application

Low/moderate root

caries activity

Group 1 - 137 (total), 81 (active),

56 (arrested) Group 2 –

133, 82, 51, respectively Group 3 –

125, 77, 48, respectively

0.5 ppm F in drinking water

Yes 8 mos after

baseline

Root surfaces

with lesions

Cavitated Also

evaluated caries activity

using a new system

based on texture, contour,

location and color of root

caries lesions

Significant reduction in number of active root

caries lesions between group

1 and 2 vs. group 3

(p < 0.02) FAVORS 5000 ppm dentrifice

Not reported

RCT

106

Cutress

199298

10-15 years

French Polynesia

no

5000 ppm/200 times a

year/once daily/supervised

in school

1250ppm F toothpaste

No High None Xylitol in 1 treatment

group No 3 year

Mean DMFT

WHO - cavitated

Not provided Not

discussed CCT

# RCT – group of subjects were randomly allocated; CCT – group of subjects were divided but word “random” not used in the paper; GRCT – a

group of school classes or communities were randomly allocated; GCCT – group of school classes or communities were divided but word “random”

not used in the paper

Table T: Risk of bias assessment of studies on prescription-strength 0.5% fluoride (home-use) pastes

Citation Summary risk of bias score

Were patients in both arms recruited from the same population at the

same time?




Allocation concealment (selection bias, protects assignment sequence

before and until allocation) e.g. opaque

enveloped holding assignment number

Blinding (ascertainment bias, protects sequence after allocation) –



similar between tx

groups*

Baseline caries status of those lost to follow-up similar to those

remaining*


groups at end of study or adjustment for

confounding*

Sample size

estimated apriori

Intention to treat used?*

Conflict of

Interest absent?

Nordstrom 2010

88

9 Yes Yes Yes No

Single blind (Examiner)

Similar Similar Yes Yes No Yes

Ekstrand, 2008

89

6

Yes Yes Yes Unclear Examiner and

patient No Unclear

no significant inter-group difference concerning

number of active lesions or

arrested lesions

No No Yes

Cutress 1992

98

2 Yes Unclear Unclear Unclear Unclear Unclear Unclear Unclear No No Yes

107

Table U: Outcomes data from studies on prescription-strength 0.5% fluoride (home-use) pastes


data

Nordstrom 201088

DFS Incidence (combined

compliance groups) 1.12 1.23 104 1.46 1.61 107

Prevalence data; proximal

incidence; Compliance A vs

B; proximal progression;

prevented fraction

DFS progression (combined

compliance groups) 1.28 1.50 104 2.13 2.10 107

Ekstrand, 200889

New active and arrested lesions

Change in status of baseline active and

arrested lesions

New active / New Arrested

Group 2 18 / 18

NA Group 2 = 64

New active / New Arrested

Group 3 41 / 11

NA Group 3 = 54

Total number of lesions

Characterization of the participants as to whether the root caries status became better, stayed stable or worsened during

the study

Cutress 199298

Mean DMFT

11 years, 5000 ppm, mean=2.6


Combined, 2.6

Calculated combined SD=3.2

11 years, 5000 ppm, n=77

12 years, 5000 ppm, n=65



Combined, 4.2

Calculated combined SD=4.2

11 years, 1250 ppm, n=46

12 years, 1250 ppm, n=19

% DMFT; tooth level DMFT

108

Table V: Characteristics of studies on prescription-strength 0.5% fluoride (home-use) gels


Population?

Intervention (Dose/duration

/ frequency) Control

Prior Prophylaxis


Baseline score

(approx.)



patients with caries

experience?

Follow-up duration

Compliance Outcome measure

Diagnostic criteria

Reported result

Adverse events

Study Design

Van Rijkom 2004

94

Truin 2005 93

4.5 – 6.5

Netherlands

Children

1% NaF for 4 min every 6

months (applied in a tray)

Placebo No

prophylaxis Low risk DMFS = 0

Low water F

Low risk (no cavitated lesions at baseline)

4 years Professional application

DMFS and dmsf– all

teeth Cavitated

Statistically

significant favoring

NaF

Not assessed

RCT

Truin 2005 91

Truin 2007

92

9.5 – 11.5

Netherlands

Children

1% NaF for 4 minutes every 6 months (applied

in a tray)

Placebo No

professional prophylaxis

Low risk DMFS = 0

Low water F

Fluoride Toothpast

e

Low risk (no cavitated lesions at baseline)

4 years Professional application

DMFS – all teeth

Cavitated Not

significant Not

assessed RCT

Englander 1971

97

11 - 15

United States

Children

1.1% NaF gel with 0.1M

phosphate for 3 minutes 3 days

a week

No Tx No

prophylaxis Unclear DMFS > 3 1ppm F

No (although low risk

population)

27-31 months

Supervised application in school settings

DMFS – all teeth


Not assessed

RCT

Englander 1978

96

2 – 6 United States

Children

1:1% NaF gel with 0.1M phosphate

thrice weekly for 3 minutes

Placebo No

prophylaxis Low caries increment

defs > 2

1 ppm F in water; F

free toothpaste

No 28 months


defs cavitated Not

significant Not

assessed RCT

Englander 1967

117

11 - 14

Unites States

Children

1. 1:1 % NaF gel with 0.1M

phosphate everyday; 2. 1:1

NaF gel everyday (excluding

summer break) for 6 minutes

No tx No

prophylaxis Unclear

DMFS > 10

Low water F; F-free

toothpaste No 21 months


DMFS – all teeth

Cavitated

Significant favoring F vs control.

No significant difference for APF vs

neutral

None observed

RCT

Gisselsson 1999

90

13 Sweden Children

1% NaF or 1% Snf four times a

year; applied with floss

Placebo No

prophylaxis Unclear DFS > 2

F toothpaste

and low water F

No 3 years Professional

ly applied

DFS – approxmal

from canine to

2M

All stages, WSL,

Cavitated

Significant favoring F.

The majority of

caries incidence

was attributable to incipient

lesions

Not assessed

RCT

109

Table W: Risk of bias assessment of studies on prescription-strength 0.5% fluoride (home-use) gels

Citation

Summary risk of bias

score

Were patients in both arms

recruited from the same

population at the same time?










Rate of losses

to follow-

up similar

between tx

groups

Baseline caries


remaining

Baseline caries status similar

between tx groups at

end of study or

adjustment for

confounding

Sample size

estimated apriori



Van Rijkom 2004

94

Truin 2005 93

10 Yes Yes Yes Yes Examiner, patient and statistician

Yes Yes Yes No Yes Yes

Truin 2005 91

Truin 2007

92

10 Yes Yes Yes Yes


Yes Unclear Yes Yes Yes Yes

Englander 1971

97


Englander 1978

96

4 yes Yes No Unclear Unclear Yes Unclear Unclear No No Yes

Englander 1967

117

5 Yes Yes No Unclear Examiner Unclear Unclear yes No No Yes

Gisselsson 1999

90

6 Yes Yes No Unclear


No Unclear Yes No No Yes

110

Table X: Outcomes data from studies on prescription-strength 0.5% fluoride (home-use) gels


data

Van Rijkom 2004 94

Truin 2005 93


0.78 1.48 340 1 1.47 336 Surface scores available, Percent progressed and

regressed Mean Increment dmfs Cavitated

1.80 3.13

340 2.34 3.67

336

Truin 2005 91

Truin

200792


0.94 1.57 269 1.18 2.17 261

Surface scores

available, Percent

progressed and

regressed; second

molar only data

available

Englander 197197

Mean DMFS increment –

cavitated 1.57 2.62 337 2.20 2.97 220

Examination

specific data

available

Englander 1978 96

Mean defs

increments - cavitated

1.79 2.61 (calculated) 46 2.11 2.86 (calculated) 44 Surface scores

available

Englander 1967 117

Mean Increment NaF vs control

DMFS - cavitated 0.89 4.18 151 4.39 4.47 195

Mean Increment Acidulated NaF vs.

control DMFS - cavitated

1.10 3.47 154 4.39 4.47 195

Mean Increment NaF & APF DMFS

cavitated 1.00 3.84 305 4.39 4.47 195

Mean Increment NaF vs. Control

DMFT - cavitated 0.90 1.84 151 2.75 2.37 195

111

Mean Increment Acidulated NaF vs.

Control DMFT - cavitated

1.00 1.99 154 2.75 2.37 195

Mean Increment NaF & APF DMFT

cavitated 0.95 1.92 305 2.75 2.37 195

Gisselsson 199990

Incidence DFS (all stages)

2.78 3.73 97 3.98 4.63 98

Incidence DS

(WSL) 2.26 3.24 97 3.48 4.31 98

Incidence DS (cavitated)

0.12 0.79 97 0.12 0.85 98

112

Table Y: Characteristics of studies on 0.09% fluoride mouthrinse


Population?

Intervention (Dose/

duration/ frequency)

Control

Caries risk

status as

stated by

authors

Baseline score

(approximate)



with caries experience?

Follow-up

duration Compliance

Outcome measure

Diagnostic criteria

Reported result

Adverse events

Study Design

Wyatt 2004

109

83 Canada Long-term care elders

Daily rinsing 0.2% NaF

Placebo Unclear DMFS > 100 Some used F

toothpaste No 2 years

Similar between groups

Coronal and root caries

Incidence and

reversals all teeth

and surfaces


NaF

Not assessed

RCT

Van Wyk 1986

108

12 -13

South Africa

Children

Weekly rinsing with 0.2% NaF

rinse

Placebo Unclear DFS > 8

Low water F; topical

fl and fl tablets

were noted when

present

No 3 years Supervised DFS – all teeth and surfaces


NaF

Not assessed

RCT

Driscoll 1981

99,

1982100

12.8

United States

Children

Weekly and daily rinsing

with 0.2% NaF for one

minute

Placebo Unclear DMFS > 4 Optimum water F

No 30

months Supervised

DMFS – all teeth


NaF

Not assessed

RCT

Heifetz 1981

102, 103

10 - 12

Unites States

Children

Weekly and daily rinsing with 0.2%

NaF for one minute

Placebo Unclear DMFS > 5 Non F No 3 years Supervised DMFS – all teeth

Cavitated

Significant favoring NaF vs control.

No significant difference between weekly

and daily

Not assessed

RCT (data

reported by

examiner)

Craig 1981

101

11 - 12

New Zealand

Children

Weekly rinsing with 0.2% NaF +

OHI and prophylaxis

OHI and Prophylaxis

high DFS > 10 No No 21

months Unknown

DFS –all teeth


NaF

Not assessed

RCT

Ringelberg 1982

106

12.5 United States

Children

Weekly and daily rinsing

with 0.2%NaF for one minute

Placebo Unclear DMFS > 4 Low water

F No 2 years Supervised

DMFS – all teeth

Cavitated Not

significant Not

assessed RCT

113

Horowitz 1971

104

6 & 10

United States

Children

Weekly rinsing with 0.2% NaF

for 1 minute

Placebo monthly

Unclear (low ses)

6 yr olds DMFS > 0.79;

10 yr olds DMFS > 6.36

Low water F

No 20

months Supervised

DMFS, DMFT


NaF

Not assessed

RCT

Torell 1965

107

10 Sweden Children

Bi-weekly Rinsing with 0.2% NaF

rinse

No treatment

Unclear DMFS > 14 Low water

F No 2 years Supervised

DMFS all teeth


NaF

Not assessed

GRCT (adjusted

for clustering in meta-analysis)

Poulsen 1983

105

7 - 9

Denmark Children Bi-weekly

rinsing with 0.2% NaF

Placebo Unclear DMFS> 3 Low water F, Used F toothpaste

No 3 years Supervised DMFS all teeth and surfaces

Cavitated

Significant for teeth erupting

during the trial

Not assessed

RCT

Chikte 1996

111

6 -12

South Africa

Children Weekly


No rinse Unclear DMFS < or = 1

Low water F;

Supervised daily F

tooth paste brushing

No 3 years Supervised

DMFS and

DMFT all teeth and surfaces

All stages Significant favoring F

rinse

Not assessed

GCCT (adjusted

for clustering in meta-analysis)

Liefde 1989

110

5-8 New

Zealand Children

Bi-weekly rinsing with 0.2% NaF

Placebo

High-risk

based on

caries score

deft >3 and decayed first permanent

molar

Low water F

Yes 3 years Supervised DMFT Cavitated Non

significant Not

assessed RCT

Corpus 1973

112

8 - 10

Philippines Children Bi-weekly


Placebo Unclear DMFT > 1.38 Low water

F, No F toothpaste

No 2 years Supervised DMFT All Stages Not

significant None

observed CCT

114

Table Z: Risk of bias assessment of studies on 0.09% fluoride mouthrinse

Citation Risk of

bias score


same population

at the same time?






until allocation)




between tx groups

Baseline caries



those remaining

Baseline caries status

similar between tx

groups at end of study or adjustment

for confounding

Sample size

estimated apriori


Conflict of

Interest absent?

Wyatt 2004109

6

Yes Yes Unclear Unclear Examiner and

patient Unclear Yes No Yes No Yes

Van Wyk 1986

108

6 Yes Yes Unclear Unclear Examiner and

patient Yes Unclear Yes No No Yes

Driscoll 1982

100



Heifetz 1981

102


Craig 1981101

5 Yes Yes No Unclear Unclear Yes Unclear Yes No No Yes

Ringelberg 1982

106

5 Yes Yes Yes Unclear Examiner and

patient Unclear Unclear Unclear No No Yes

Horowitz 1971 104

7 Yes Yes No Unclear Examiner Yes Yes Yes No No Yes

Torell 1965107

6 Yes Yes No No Examiner Yes Unclear Unclear Yes No Yes

Poulsen 1983

105


patient Yes

(small) Yes Yes No No Yes

Chikte 1996111

3 Yes No No No No Yes Unclear Unclear No No Yes

Liefde 1989 110

5 yes Yes No Unclear


yes Unclear Unclear No No Yes

Corpus 1973 112

4 Yes No No No Unclear Yes Yes Unclear No No Yes

115

Table AA: Outcomes data from studies on 0.09% fluoride mouthrinse


data

Wyatt 2004109

Caries increment – crown DMFS

cavitated 0.4 2.5 39 0.8 2.4 36

Root increment; Reversals; Root

reversals Caries increment –

root DMFS cavitated 0.3 3.1 39 2.2 3.8 36

Van Wyk 1986108

DFS increment -

cavitated 4.6 4.4 185 7.5 5.7 192

Prevalence difference; SD estimated from

Cochrane equation

Driscoll 1982100


cavitated weekly rinsing-- examiner 1

2.01 2.78 81 2.58 3.19 77

Surface level ; daily rinsing

SD were not stated; imputed according to the

Cochrane Equation


cavitated weekly rinsing-- examiner 2

0.85 1.73 84 1.89 2.69 74


cavitated weekly rinsing-- calculated

combined data

1.42 2.30 165 2.24 2.96 151


cavitated daily rinsing-- examiner 1

1.86 2.67 102 2.58 3.19 77


cavitated daily rinsing-- examiner 2

0.95 1.84 106 1.89 2.69 74

116


cavitated daily rinsing-- calculated

combined data

1.76 2.59 208 2.24 2.96 151

Heifetz 1981102, 103

Mean DMFS increment Cavitated

weekly rinsing-- examiner 1

2.25 3.94 97 3.61 6.06 87

Surface level ; daily rinsing;

reversal in 2 yr results


weekly rinsing-- examiner 2

3.39 3.94 102 4.43 4.98 117


cavitated weekly rinsing-- calculated

combined data

2.83 3.94 199 4.08 5.47 204


daily rinsing-- examiner 1

1.90 4.03 88 3.61 6.06 87


daily rinsing-- examiner 2

2.94 3.41 107 4.43 4.98 117


cavitated daily rinsing-- calculated

combined data

2.47 3.90 195 4.08 5.47 204

Craig 1981101

DFS caries

increment Cavitated 1.8 2.7 49 2.6 3.1 48

Surface level score available;

Ringelberg 1982

106

DMFS increment Cavitated weekly

2.66 3.98 253

3.34 4.42 249 Daily rinse; approximal

DMFS increment 2.58 3.85 257

117

Cavitated daily

Horowitz 1971 104

DMFS increment cavitated—6 year

old 1.08

1.96 133 1.29

1.89 123

DMFT, eruption, surface

DMFS increment cavitated—10 year

old 1.65

2.77 98 2.92

4.20 110

DMFS increment cavitated—

calculated combined 1.32 1.74 231 2.06 3.20 233

DMFT increment cavitated—6 year

old 0.54 1.15 133 0.72

1.00 123

DMFT increment cavitated—10 year

old 0.79 1.68 98 1.63

2.62 110

DMFT increment cavitated—

calculated combined 0.64 1.40 231 1.15 1.94 233

Torell 1965107

DMFS increment-

cavitated 5.10 4.93 160 10.02 6.75 162

Poulsen 1983105

Mean DMFS increment-cavitated

1.75 2.37 191 1.83 2.20 174

Data by erupting and erupted teeth and by surfaces.

Mean DMFS increment-caviated, Newly erupted teeth

0.73 1.31 191 0.99 1.52 174

Chikte 1996111

DMFS increment -

Cavitated 1.054 2.54 603 1.245 2.65 642

Surface level data available;

eruption; tooth type; prevalence’

Liefde 1989 110

DMFT prevalence

cavitated 2.9 1.2 101 2.7 1.2 172

Mean score in proximal and anterior teeth

available; high and low caries risk; defs tooth

score

Corpus 1973 112

DMFT all stages caries increment

1.12 1.34 80 1.68 1.61 72 erupting

118

Appendix 5 - Pragmatic calculations for interpreting summary

estimates clinically The standardized mean difference (SMD) is the chosen summary estimate.

The relationship of the absolute value of the SMDs to prevented fractions (PF) was investigated.

A correlation equation was generated from topical fluoride systematic reviews (Marinho et al12-14,

118) as follows:

The equation to convert SMD to PF is: PF=0.75*│SMD│+ 0.08 Note that this equation is not generalizable to studies of outcomes other than DMFS and should not be extrapolated beyond the ranges of SMD and PF used in its generation. To convert PF to number needed to treat (NNT), the following equation was used (assuming

“prevented fraction” is equivalent to “preventive fraction”):

PF=1-RR;

RR=ERt/ERc => ERt=RR(ERc)

NNT=1/(ERc-ERt) = 1/(ERc-RR(ERc)) = 1/(ERc*(1-RR)) = 1/(ERc*PF)

Where RR is the risk ratio; ER is the event rate; ERc is the control event rate; ERt is the

treatment event rate. For example, if for an at-risk population, the ERc is set at 1 DMFS per

year, then NNT = 1/PF.

Documents

Topical fluoride for caries prevention - Geriatric Dentistry · of developing dental caries: 2.26% fluoride varnish or 1.23% fluoride (APF) gel, or a prescription-strength, home-use